Diabetic Gastroparesis Study 05

NCT03786380 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: 3071-305-0202019-000406-30
• Study Type: interventional
• Target: 202
• Locations: 29 countries
• Sites: 478

Brief Summary

This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 \[NCT03420781\] or RLM-MD-04 \[NCT03383146\] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

Conditions

Gastroparesis

Keywords

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

  Up to approximately 22 months

• Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results

  Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  Baseline (Day 1) up to approximately 22 months

• Number of Participants With Clinically Meaningful Trends for Vital Signs

  Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

  Up to approximately 22 months

• Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results

  A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

  Up to approximately 22 months

Study Arms (1)

Relamorelin 10 μg

EXPERIMENTAL

Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.

Drug: Relamorelin 10 μg

Interventions

Relamorelin 10 μg DRUG

Relamorelin 10 μg injected subcutaneously twice daily.

Relamorelin 10 μg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
• Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
• Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.

You may not qualify if:

• Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
• Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
• Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease
• Females who are pregnant, nursing, or planning a pregnancy during the study.

Sponsors & Collaborators

• Allergan: lead

Study Sites (486)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

North Alabama Research Center, LLC

Athens, Alabama, 35611, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35295, United States

Location

Digestive Health Specialist of the South East

Dothan, Alabama, 36305, United States

Location

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

Alabama Medical Group, PC

Mobile, Alabama, 36608, United States

Location

Del Sol Research Management, LLC

Chandler, Arizona, 85224, United States

Location

Phoenix Clinical LLC.

Phoenix, Arizona, 85014, United States

Location

Adobe Clinical Research LLC

Tucson, Arizona, 85712, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85712, United States

Location

Preferred Clinical Research Partners

Little Rock, Arkansas, 72205, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

HCP Clinical Research LLC

Anaheim, California, 92801, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

GW Research Inc

Chula Vista, California, 91910, United States

Location

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879, United States

Location

Aurora Care Clinic, LLC

Costa Mesa, California, 92627, United States

Location

Diagnamics Inc.

Encinitas, California, 92024, United States

Location

Valley View Wellness and Medical Center - VVCRD Clinical Research

Garden Grove, California, 92845, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

Torrance Clinical Research Institute, Inc.

Lomita, California, 90717, United States

Location

Tibor Rubin VA Medical Center

Long Beach, California, 90822, United States

Location

Angel City Research Inc.

Los Angeles, California, 90057, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Stanford Hospital

Palo Alto, California, 94304, United States

Location

TriWest Research Associates

Poway, California, 92064, United States

Location

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

Medical Associates Research Group, Inc

San Diego, California, 92123, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Upland Clinical Research

Upland, California, 91786, United States

Location

New Hope Research Development

Whittier, California, 90603, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Denver Esophageal and Stomach Center

Englewood, Colorado, 80110, United States

Location

Gastroenterology Associates of Fairfield County, P.C.

Bridgeport, Connecticut, 06606, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, United States

Location

Gastro Florida

Clearwater, Florida, 33756-3839, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

ALL Medical Research LLC

Cooper City, Florida, 33024, United States

Location

American Research Institute, Inc

Cutler Bay, Florida, 33157, United States

Location

Top Medical Research

Cutler Bay, Florida, 33189, United States

Location

Palmetto Research, LLC

Hialeah, Florida, 33016, United States

Location

Vida Clinical Trials

Homestead, Florida, 33030, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

University of Florida

Jacksonville, Florida, 32207, United States

Location

Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

Cfagi Llc

Maitland, Florida, 32751, United States

Location

APF Research LLC

Miami, Florida, 33134, United States

Location

AMPM Research Clinic

Miami, Florida, 33169, United States

Location

Advanced Medical Research Institute

Miami, Florida, 33174, United States

Location

Florida Research Center, Inc.

Miami, Florida, 33174, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Savin Medical Group LLC

Miami Lakes, Florida, 33014, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Sensible Healthcare

Ocoee, Florida, 34761, United States

Location

Gulf Region Clinical Research Institute

Pensacola, Florida, 32514, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Gastro Florida

Tampa, Florida, 33626, United States

Location

Cleveland Clinic Florida - Weston

Weston, Florida, 33331, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

Gwinnett Research Institute

Buford, Georgia, 30519, United States

Location

Summit Clinical Research, LLC.

Carnesville, Georgia, 30521, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Infinite Clinical Trials

Riverdale, Georgia, 30274, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center, PA

Idaho Falls, Idaho, 83404-7596, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

American Research, LLC

Jeffersonville, Indiana, 47130, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Integrated Clinical Trial Services Inc

West Des Moines, Iowa, 50265, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Health Science Research Center

Pratt, Kansas, 67124, United States

Location

Cotton-O'Neil Clinical Research Center - Digestive Health

Topeka, Kansas, 66606, United States

Location

Professional Research Network of Kansas, LLC

Wichita, Kansas, 67205-1138, United States

Location

Via Christi Clinic, PA

Wichita, Kansas, 67208, United States

Location

Tri-State Gastroenterology

Crestview Hills, Kentucky, 41017, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Delta Research Partners

Bastrop, Louisiana, 71220, United States

Location

Avant Research Associates LLC

Crowley, Louisiana, 70526, United States

Location

Cronola LLC

Houma, Louisiana, 70630, United States

Location

Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

New Orleans Research Institute - Metropolitan Gastroenterology Associates

Metairie, Louisiana, 70006, United States

Location

Clinical Trials of America, Inc.

West Monroe, Louisiana, 71291, United States

Location

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Woodholme Gastroenterology Associates, P.A.

Glen Burnie, Maryland, 21061, United States

Location

Commonwealth Clinical Studies, PLLC.

Brockton, Massachusetts, 02302, United States

Location

Coastal Research Associates, Inc.

South Weymouth, Massachusetts, 02190, United States

Location

Boston VA Healthcare System

West Roxbury, Massachusetts, 02130, United States

Location

Biocon Clinical Research, LLC

Caro, Michigan, 48723, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Aa Mrc, Llc

Flint, Michigan, 48504, United States

Location

National Clinical, LLC

Hamtramck, Michigan, 48212, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Troy Gastroenterology, PC dba Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

MNGI Digestive Health

Coon Rapids, Minnesota, 55446, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Heartland Clinical Research, Inc

Omaha, Nebraska, 68134, United States

Location

Clinical Research of South Nevada

Las Vegas, Nevada, 89121, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

Digestive Disease Specialists

Las Vegas, Nevada, 89128, United States

Location

Palm Research Center

Las Vegas, Nevada, 89135, United States

Location

Test Center 3

Brick, New Jersey, 08723, United States

Location

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, 08234, United States

Location

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States

Location

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

United Health Services Hospitals, Inc.

Johnson City, New York, 13760, United States

Location

NYU Winthrop Hospital, Clinical Trials Center

Mineola, New York, 11501, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Asheville Gastroenterology Associates

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7080, United States

Location

Test Center 2

Charlotte, North Carolina, 28204, United States

Location

PMG Research of Charlotte, LLC

Concord, North Carolina, 28025, United States

Location

Carolina Digestive Health Associates, PA

Davidson, North Carolina, 28036, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, 28304, United States

Location

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

Location

Vidant Multispeciality Clinic - Kinston

Kinston, North Carolina, 28501, United States

Location

Diabetes and Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, United States

Location

PMG Research Salisbury

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Dayton Gastroenterology,Inc.

Beavercreek, Ohio, 45440, United States

Location

The MetroHealth System MHS

Cleveland, Ohio, 44109-1998, United States

Location

Digestive Disease & Surgery Institute

Cleveland, Ohio, 44195, United States

Location

Endocrinology Research Associates, Inc.

Columbus, Ohio, 43201, United States

Location

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43203, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213, United States

Location

Hometown Urgent Care and Research

Columbus, Ohio, 43214, United States

Location

Clinical Inquest Center Ltd.

Dayton, Ohio, 45409, United States

Location

Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Memorial Clinical Research

Oklahoma City, Oklahoma, 73120, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Family Medical Associates, Research Department

Levittown, Pennsylvania, 19056, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, 15236, United States

Location

Guthrie Clinical Research

Sayre, Pennsylvania, 18840, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Montgomery Medical, Inc.

Smithfield, Pennsylvania, 15478, United States

Location

Preferred Primary Care Physicians, Jacob Murphy

Uniontown, Pennsylvania, 15401, United States

Location

Partners in Clinical Research, LLC

Cumberland, Rhode Island, 02864, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Gastroenterology Associates, PA

Greenville, South Carolina, 29615, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Clinsearch

Chattanooga, Tennessee, 37421, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Avant Research Associates,LLC

Austin, Texas, 78704, United States

Location

DiscoveResearch, Inc.

Beaumont, Texas, 77701, United States

Location

ClinRx Research, LLC

Carrollton, Texas, 75007, United States

Location

Texas Tech University Health Sciences, Center Division of Gastroenterology

El Paso, Texas, 79905, United States

Location

DHAT Research Institute

Garland, Texas, 75044, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Biopharma Informatic Inc., Research Center

Houston, Texas, 77043, United States

Location

Rodriguez Clinical Trials

Houston, Texas, 77083, United States

Location

Amir Ali Hassan, MD, PA

Houston, Texas, 77089, United States

Location

Digestive Center of South Texas

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

SAGACT PLLC., San Antonio Gastroenterology Associates, PA

San Antonio, Texas, 78229, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Advanced Research Institute, Inc.

Ogden, Utah, 84405, United States

Location

Test Center

Salt Lake City, Utah, 84124, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Verity Research Inc.

Fairfax, Virginia, 22031, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Manassas Clinical Research Centre

Manassas, Virginia, 20110, United States

Location

VA Medical Center McGuire VAMC

Richmond, Virginia, 23249, United States

Location

Test Center 4

Roanoke, Virginia, 24014, United States

Location

Cardinal Internal Medicine

Woodbridge, Virginia, 22192, United States

Location

Washington Gastroenterology PLLC

Tacoma, Washington, 98405, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Maffei Centro Medico-Investigacion Clinica Aplicada

C.a.b.a., Buenos Aires, C1425AGC, Argentina

Location

Hospital Sirio Libanes

CABA, Buenos Aires, C1419AHN, Argentina

Location

CIPREC

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1119, Argentina

Location

Instituto de Investigaciones Clínicas de Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Instituto de hematología y medicina clínica "Dr. Rubén Dávoli"

Rosario, Santa Fe Province, S200CFK, Argentina

Location

Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, W3402BKE, Argentina

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Ordination

Saint Stefan, Styria, 8511, Austria

Location

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, A-6020, Austria

Location

VIVIT Institute, am LKH Feldkirch

Feldkirch, Vorarlberg, 6800, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Privatklinik Wehrle-Diakonissen

Salzburg, 5026, Austria

Location

Oö. Gesundheits- und Spitals-AG/LKH Steyr

Steyr, 4400, Austria

Location

Krankenanstalt Rudolfstiftung Wien

Vienna, 1030, Austria

Location

KH Hietzing

Vienna, 1130, Austria

Location

AZ Sint Lucas Brugge

Bruges, Antwerpen, 2650, Belgium

Location

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

Edegem, Antwerpen, 2650, Belgium

Location

Hôpitaux Iris Sud - Joseph Bracops

Brussels, 1070, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

CHC - Clinique Saint-Joseph

Liège, 4000, Belgium

Location

Hospital Universitário Walter Cantídio

Fortaleza, Ceará, 60430-370, Brazil

Location

Centro de Pesquisa Clinica do Brasil

Brasília, Federal District, 71625175, Brazil

Location

Quanta Diagnóstico e Terapia

Curitiba, Paraná, 80030-110, Brazil

Location

Hospital Universitário João de Barros Barreto - UFPA

Belém, Pará, 66073-000, Brazil

Location

Hospital Sao Vicente de Paulo

Passo Fundo- RS, Rio Grande do Sul, 99010-080, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

Hospital São Lucas da PUC-RS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Instituto Catarinense de Endocrinologia e Diabetes (ICED)

Joinville, Santa Catarina, 89201-260, Brazil

Location

Scentryphar Pesquisa Clínica Ltda

Campinas, São Paulo, 1302-431, Brazil

Location

Instituto de Pesquisa Clínica em Campinas

Campinas, São Paulo, 13060904, Brazil

Location

Universidade de Sao Paulo (USP) - Hospital das Clinicas da F

Cerqueira Cesar - Sao Paulo, São Paulo, Cep 05403-000, Brazil

Location

IPEC-Instituto de Pesquisa Clinica

São Paulo, São Paulo, 01223-001, Brazil

Location

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology

Fortaleza, 60160-230, Brazil

Location

MHAT Yuliya Vrevska Byala

Byala, 1303, Bulgaria

Location

MHAT Dobrich AD

Dobrich, 9300, Bulgaria

Location

MHAT Dr. Tota Venkova AD

Gabrovo, 5300, Bulgaria

Location

UMHAT - Kaspela- EOOD

Plovdiv, 4002, Bulgaria

Location

Medical Center Asklepion - Humane Medicine Research EOOD

Sofia, 1303, Bulgaria

Location

Alexandrovska University Hospital

Sofia, 1431, Bulgaria

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2E1, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

Eastern Health

St. John's, Newfoundland and Labrador, NL A1B 3V6, Canada

Location

South Shore Medical Arts

Bridgewater, Nova Scotia, B4V 2V6, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Etobicoke, Ontario, M9V4B4, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

CISSS de la Monteregie-Centre

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1M 1B1, Canada

Location

Centre Hospitalier de l'Universite de Montreal - CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

Central Alberta Research Centre

Red Deer, T4N 6V7, Canada

Location

Toronto Digestive Disease Associates

Vaughan, L4L 4YZ, Canada

Location

Rodrigo Botero S.A.S.

Medellín, Antioquia, 50030, Colombia

Location

Centro Cardiovascular y de Diabetes

Barranquilla, Atlántico, 80020, Colombia

Location

Fundación BIOS

Barranquilla, Atlántico, 80020, Colombia

Location

Endocare Ltda.

Bogota, Cundinamarca, 111111, Colombia

Location

Healthy Medical Center

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Medplus Medicina Prepagada

Bogotá, Distrito Capltal, 110221, Colombia

Location

Centro Medico Imbanaco de Cali S.A.

Cali, Distrito Capltal, 760042, Colombia

Location

IPS Centro Medico Julian Coronel S.A

Cali, Valle del Cauca Department, 760035, Colombia

Location

Gastroenheden, Hvidovre hospital

Hvidovre, Kobenhavn, 2605, Denmark

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Steno Diabetes Center Copenhagen

Hellerup, 2900, Denmark

Location

Nordsjaellands Hospital

Hilleroed, 3400, Denmark

Location

MEA KFA

Aarhus, Århus, 8000, Denmark

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, Gironde, 33604, France

Location

Hôpital Louis-Mourier

Colombes, 92700, France

Location

Corbeil Essonnes

Corbeil-Essonnes, 91106, France

Location

Service d'hépato-gastroentérologie - 7°D

Grenoble, 38043, France

Location

Hospices Civils de Lyon - Hôpital Edouard Herrriot

Lyon, 69437, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Centre de Recherche Clinique

Vénissieux, 69200, France

Location

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Baden-Wurttemberg, 76137, Germany

Location

Praxis Dr. Etzrodt-Walter und Kollegen

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Diabetologische Schwerpunktpraxis

Bad Berleburg, North Rhine-Westphalia, 57319, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 0 1309, Germany

Location

Studienzentrum Schwittay

Böhlen, 4564, Germany

Location

Universitätsklinikum Giessen und Marburg GmbH

Giessen, 32392, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Clinical Research Hamburg GmbH

Hamburg, 22143, Germany

Location

Israelitisches Krankenhaus

Hamburg, 22297, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, 30159, Germany

Location

KRH Klinikum Siloah

Hanover, 30459, Germany

Location

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Heves County, H-3300, Hungary

Location

Coromed SMO

Pécs, Pécs, 7623, Hungary

Location

First Department of Medicine, University of Szeged

Szeged, Szaged, 6720, Hungary

Location

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Zala County, H-8900, Hungary

Location

Semmelweis University

Budapest, H-1088, Hungary

Location

Stra¡zshegy Medicina

Budapest, H1171, Hungary

Location

Hetenyi Geza Hospital

Szolnok, H-5004, Hungary

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res

Ahmedabad, Gujarat, 380007, India

Location

Zydus Hospital

Ahmedabad, Gujarat, 380054, India

Location

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, 395002, India

Location

Lifecare Clinic and Research Centre - Internal Med/Diabetolo

Bangalore, Karnataka, 560092, India

Location

Diacon Hospital and research Center

Bengaluru, Karnataka, 359-360, India

Location

Victoria Hospital Bangalore Medical College and Research Ins

Bengaluru, Karnataka, 560002, India

Location

Rajalakshmi Hospital

Bengaluru, Karnataka, 560097, India

Location

Vinaya Hospital & Research Centre

Mangalore, Karnataka, 575003, India

Location

Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute

Nashik, Maharashtra, 422005, India

Location

B. J. Government Medical College and Sassoon General Hospitals

Pune, Maharashtra, 411001, India

Location

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

University Hospital

Pune, Maharashtra, 411011, India

Location

Noble Hospital

Pune, Maharashtra, 411013, India

Location

S.P.Medical College & Group of Hospitals Bikaner

Bikaner, Rajasthan, 334003, India

Location

S.R. Kalla Memorial Gastro and General Hospital

Jaipur, Rajasthan, 302001, India

Location

Sawai Man Singh Hospital

Jaipur, Rajasthan, 302004, India

Location

Sir Ganga Ram Hospital (SGRH)

Jaipur, Rajasthan, 302006, India

Location

Marudhar Hospital

Jaipur, Rajasthan, 302012, India

Location

Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.

Jaipur, Rajasthan, 302017, India

Location

Madras Medical College & Rajiv Gandhi Govt. General Hospital

Chennai, Tamil Nadu, 600003, India

Location

M.V. Hospital for Diabetes & Diabetes Research Centre

Chennai, Tamil Nadu, 600013, India

Location

Kovai Diabetes Speciality Centre

Coimbatore, Tamil Nadu, 641009, India

Location

Arthur Asirvatham Hospital

Madurai, Tamil Nadu, 625020, India

Location

M V Hospital & Research Centre

Lucknow, Uttar Pradesh, 226003, India

Location

IPGME&R and SSKM Hospital

Kolkata, West Bengal, 700020, India

Location

M. S. Ramaiah medical College and Hospitals - Gastroenterolo

Bangalore, 560054, India

Location

Gleneagles Global Hospital

Hyderabad, 500004, India

Location

Kumudini Devi Diabetes Research Center

Hyderabad, 500072, India

Location

Bhatia Hospital

Mumbai, 400007, India

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Bnai Zion M.C.

Haifa, 31048, Israel

Location

E. Wolfson Medical Center

Holon, 58100, Israel

Location

Digestive Diseases Institute

Jerusalem, 9103102, Israel

Location

Gastroenterology Institute

Petah Tikva, 49100, Israel

Location

Endocrinology & Diabetes Center

Safed, 13100, Israel

Location

Gastroenterology Institute

Tel Aviv, 64239, Israel

Location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Clinical Institute Beato Matteo

Vigevano, Pavia, 27029, Italy

Location

Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo

Rome, Rome Roma, 168, Italy

Location

Ospedale Cardinal Massaia

Asti, 14100, Italy

Location

University of Bari

Bari, 70121, Italy

Location

Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi

Catania, 95122, Italy

Location

Universita Magna Graecia di Catanzaro

Catanzaro, 88100, Italy

Location

IRCCS Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Universita degli Studi di Napoli Federico II

Napoli, 80131, Italy

Location

Azienda Opsedaliera di Padova

Padua, 35128, Italy

Location

IRCCS S.Matteo Hospital Foundation, University of Pavia

Pavia, 27100, Italy

Location

University of Pisa - Cisanello Hospital

Pisa, 56126, Italy

Location

Gruppo Humanitas - Humanitas Research Hospital

Rozzano, 20089, Italy

Location

Universita' Di Salerno- Aou Ruggi D'aragona

Salerno, 80100, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Polana-D

Daugavpils, 5401, Latvia

Location

Ogorelova Jelena GP

Krāslava, 5601, Latvia

Location

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

Riga, 1002, Latvia

Location

Digestive Diseases Centre GASTRO

Riga, 1006, Latvia

Location

Hospital Sultanah Bahiyah

Alor Star, Kedah, 5460, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Universiti Sains Malaysia

Kubang Kerian, 16150, Malaysia

Location

Hospital Taiping

Taiping, 34000, Malaysia

Location

Centro de Investigacion Morales Vargas - CIMOVA

León, Guanajuato, 37000, Mexico

Location

Centro de Diabetes de Pachuca

Pachuca, Hidalgo, 42090, Mexico

Location

Unidad de Investigación Clínica Cardiometabolica de Occidente

Guadalajara, Jalisco, 44150, Mexico

Location

Consultorio Medico

Guadalajara, Jalisco, 44210, Mexico

Location

Unidad de Investigación clínica y atención Médica HEPA S.C.

Guadalajara, Jalisco, 44670, Mexico

Location

Clinicos Asociados BOCM SC

Mexico City, Mexico City, 03300, Mexico

Location

Clinica OMEGA

Mexico City, Mexico City, 14000, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion

Mexico City, Mexico City, 14080, Mexico

Location

Medical and Nutritional Trials

México DF, Mexico City, 6700, Mexico

Location

Instituto de Diabetes Obesidad y Nutrición SC

Cuautla, Morelos, 62746, Mexico

Location

Accelerium Clinical Research

Monterrey, Nuevo León, 64000, Mexico

Location

Centro Medico Christus Muguerza Sur

Monterrey, Nuevo León, 64700, Mexico

Location

Investigación Médica Sonora, S.C.

Hermosillo, Sonora, 83280, Mexico

Location

Centro Especializado en Investigación Clínica S.C.

Boca del Rio, Veracruz, 94290, Mexico

Location

Centro de Desarrollo Biomédico

Mérida, Yucatán, 97070, Mexico

Location

Practice Dr Gerardo Gonzalez

Acapulco, 39350, Mexico

Location

Hospital Cardiológica Aguascalientes

Aguascalientes, 20230, Mexico

Location

Dioderm Instituto de Investigación

Durango, 34060, Mexico

Location

CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

Durango, 34270, Mexico

Location

Sociedad de Metabolismo y Corazón, S.C.

Veracruz, 91900, Mexico

Location

Perpetual Succor Hospital

Cebu City, 6000, Philippines

Location

West Visayas State University Medical Center

Iloilo City, 5000, Philippines

Location

Ospital ng Makati

Makati City, 1218, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

San Juan De Dios Educational Foundation, Inc.

Pasay, 1300, Philippines

Location

St. Luke's Medical Center

Quezon City, 1100, Philippines

Location

Cardinal Santos Medical Center

San Juan City, 1502, Philippines

Location

NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,

Bialystok, Bia|ystok, 15-879, Poland

Location

Centrum Medyczne Pratia Warszawa

Warsaw, Warazawa, 01-868, Poland

Location

Szpital Uniwestytetu Medycznego w Bialymstoku

Bialystok, 15-276, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-065, Poland

Location

Vitamed

Bydgoszcz, 85-079, Poland

Location

Centrum Medyczne Lukamed

Chojnice, 89-600, Poland

Location

Silmedic Sp z o o

Katowice, 40 282, Poland

Location

Specjalistyczny Gabinet Neurologiczny Marta Banach

Krakow, 30-539, Poland

Location

CenterMed Krakow Ltd

Krakow, 31-530, Poland

Location

Centrum Medyczne Medyk

Lublin, 20-090, Poland

Location

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10-561, Poland

Location

Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.

Pruszków, 05-800, Poland

Location

Endoskopia SP. Z O.O.

Sopot, 81-756, Poland

Location

Powiatowe Centrum Medyczne w Wołowie

Wołów, 56-100, Poland

Location

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, 51-162, Poland

Location

Zamość

Zamość, PL 22-400, Poland

Location

Sana Medical Center

Bucharest, 11025, Romania

Location

National Institute of Endocrinology

Bucharest, 11863, Romania

Location

AMES Research Center SRL

Călăraşi, 910103, Romania

Location

ClinTrial Medical Center, Pulmonology Department

Dobrosloveni Resca, Olt County, 237143, Romania

Location

Polisano-Clinic

Sibiu, 550253, Romania

Location

Scientific Institute of Clinical and Experimental Lymphology

Novosibirsk, Novosibirsk Oblast, 630117, Russia

Location

North-Western State Medical University named after I. I. Mechnikov

Saint Petersburg, Sankt-Peterburg, 191015, Russia

Location

Millitary-medical Academy, department of hospital therapy

Saint Petersburg, Sankt-Peterburg, 191124, Russia

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Saint-Petersburg City Pokrovskaya Hospital

Leningrad Region, 199106, Russia

Location

FSBI National medical endocrinology research centre

Moscow, 117036, Russia

Location

Moscow Regional Research Clinical Institute named by MF Vladimirski

Moscow, 129110, Russia

Location

Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

Nizhny, 603126, Russia

Location

Rostov on Don

Rostov-on-Don, 344019, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

MUZ City Clinical Hospital 9

Saratov, 410030, Russia

Location

Saratov City Clinical Hospital 12

Saratov, 410039, Russia

Location

National University Hospital

Singapore, 119228, Singapore

Location

Singapore General Hospital

Singapore, 169856, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

FARMOVS

Bloemfontein, Free State, 9301, South Africa

Location

Soweto CTC

Johannesburg, Gauteng, 1818, South Africa

Location

Wits Clinical Research

Johannesburg, Gauteng, 2193, South Africa

Location

Synexus Stanza Clincal Reaserch Centre

Pretoria, Gauteng, 122, South Africa

Location

Endocare Research

Paarl, Western Cape, 7646, South Africa

Location

Synexus Helderberg Clinical Research Centre

Cape Town, 7130, South Africa

Location

TREAD Research

Cape Town, 7500, South Africa

Location

Syenxus Watermeyer Dedicated Research

Val de Grace, 184, South Africa

Location

Moriana Clinical Research

Winnie Mandela, 9400, South Africa

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Sanggye Paik Hospital, Inje University College of Medicine

Seoul, 1757, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Hospital Universitario 12 de Octubre

Madrid, 20041, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Principe de Asturias

Madrid, 28850, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

State Institution Ukrainian State Research Institute

Dnipro, Dnipropetrovsk Oblast, 49027, Ukraine

Location

"Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council

Dnipropetrovsk Region, Dnipropetrovsk Oblast, 50002, Ukraine

Location

Ivano-Frankivsk National Medical University

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine

Location

Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv

Kyiv, Kyïv, 1034, Ukraine

Location

DRRI-Vinnytsia National Pirogov Memorial Medical University

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

Municipal Institution Lutsk City Clinical Hospital

Lutsk, Volyos'ka Oblast', 43024, Ukraine

Location

Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department

Chernihiv, 14034, Ukraine

Location

Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C

Chernivtsi, 58001, Ukraine

Location

Regional Public Organization Chernivtsi Regional Endocrinology Center

Chernivtsi, 58022, Ukraine

Location

SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine

Dnipro, 49038, Ukraine

Location

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, 76018, Ukraine

Location

Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology

Kharkiv, 61037, Ukraine

Location

"State Institution "National Institute of Therapy named after. L.T. Maloi NAMNU" / Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Department of the study of diseases of the digestive

Kharkiv, 61039, Ukraine

Location

Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine

Kharkiv, 61070, Ukraine

Location

Communal Institution Kherson City Clinical Hospital

Kherson, 73000, Ukraine

Location

Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

Kyiv, 2002, Ukraine

Location

Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department

Kyiv, 3049, Ukraine

Location

Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv

Kyiv, 3680, Ukraine

Location

Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

Kyiv, 4050, Ukraine

Location

Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine

Kyiv, 4114, Ukraine

Location

City Hospital #1, department of endocrinology, c. Mykolayiv

Mykolaiv, 54003, Ukraine

Location

Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

Odesa, 65010, Ukraine

Location

Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

Odesa, 65025, Ukraine

Location

Poltava Regional Clinical Hospital

Poltava, 36011, Ukraine

Location

Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

Sumy, 40031, Ukraine

Location

Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology

Ternopil, 46000, Ukraine

Location

Private Small-Scale Enterprise Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology

Vinnytsia, 21009/21029, Ukraine

Location

Vinnytsia Regional Clinical highly specialized Endocrinology Centre

Vinnytsia, 21010, Ukraine

Location

Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia

Vinnytsia, 21029, Ukraine

Location

6th City Clinical Hospital, c. Zaporizhzhia

Zaporizhzhia, 69035, Ukraine

Location

"Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia"

Zaporizhzhia, 69600, Ukraine

Location

Municipal Institution-Zaporizhzhia Regional Clinical Hospital

Zaporizhzhia, 69600, Ukraine

Location

Royal Oldham Hospital

Oldham, Lancashire, OL1 2JH, United Kingdom

Location

MAC Research, Exchange House

Cannock, Staffordshire, WS11 0BH, United Kingdom

Location

University Hospitals of North Midlands

Stoke-on-Trent, Staffordshire, ST6 8DG, United Kingdom

Location

MAC Research

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research, Kaman Court

Blackpool, FY2 0JH, United Kingdom

Location

Mid Essex Hospital Services NHS Trust Broomfield Hospital

Chelmsford, CM1 7ET, United Kingdom

Location

Western General Hospital Edinburgh

Edinburgh, EH4 2XU, United Kingdom

Location

MAC Clinical Research, Monarch House

Leeds, LS10 1DU, United Kingdom

Location

MAC Clinical Research

Liverpool, L34 1BH, United Kingdom

Location

Wingate Institute

London, E1 2AJ, United Kingdom

Location

University College London Hospita

London, NW1 2BU, United Kingdom

Location

MAC Clinical Research Manchester

Manchester, M13 9NQ, United Kingdom

Location

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Biomedical Research Centre

Nottingham, NG7 2UH, United Kingdom

Location

MAC Clinical Research, GAC House

Stockton-on-Tees, TS17 6EW, United Kingdom

Location

St George's Hospital

Tooting, SW17 0QT, United Kingdom

Location

Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

relamorelin

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Harvy Schneier

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: December 20, 2018
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (6); CA (15); IN (30); BE (5); ZA (9); GB (18); DE (12); LA (4); IL (7); PH (7); FR (10); CO (8); RO (5); HU (7); MY (4); PL (16); KR (3); US (189); AU (5); ES (7); AR (6); SG (3); BR (14); RU (12); IT (15); DK (5); UA (33); TH (3); ME (20)