Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

NCT03426345 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: RLM-MD-022017-002177-20
• Study Type: interventional
• Target: 311
• Locations: 15 countries
• Sites: 240

Brief Summary

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Conditions

Gastroparesis; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)

  Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0= no or not at all uncomfortable to 10= worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period.

  Baseline (Day-14 to Day-1) to Week 12

• Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

  The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.

  Week 6 to Week 12

Secondary Outcomes (10)

• Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

  Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

• Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

  Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

• Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

  Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

• Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

  Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

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

  Up to approximately 16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

Drug: Placebo

Relamorelin 10 μg

EXPERIMENTAL

Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.

Drug: Relamorelin

Interventions

Placebo DRUG

Placebo injected subcutaneously twice daily.

Placebo

Relamorelin DRUG

Relamorelin 10 μg injected twice daily for 12 weeks.

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:

• Diagnosis of Type 1 or Type 2 diabetes mellitus
• Meet the per protocol criteria of diabetic gastroparesis
• Compliance with diary
• Compliance with the per protocol study treatment dosing instructions

You may not qualify if:

• Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
• Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
• Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
• History of gastrointestinal disorders that may be similar to gastroparesis
• Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Sponsors & Collaborators

• Allergan: lead

Study Sites (240)

North Alabama Research Center, LLC

Athens, Alabama, 35611, United States

Location

Synexus Clinical Research US - Simon Williamson Clinic

Birmingham, Alabama, 35211, United States

Location

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

Alabama Medical Group, PC

Mobile, Alabama, 36608, United States

Location

Synexus Clinical Research US, Inc.

Tucson, Arizona, 85741, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Unity Health - Searcy Medical Center

Searcy, Arkansas, 72143, United States

Location

GW Research Inc.

Chula Vista, California, 91910, United States

Location

Diagnamics Inc.

Encinitas, California, 92024, United States

Location

Fresno Clinical Research Center

Fresno, California, 93720, 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, 90026, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

United Medical Doctors

Murrieta, California, 92563, United States

Location

Stanford Hospital, Digestive Health Clinic

Palo Alto, California, 94304, United States

Location

TriWest Research Associates

Poway, California, 92064, United States

Location

Optimal Research California

San Diego, California, 92108, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

New Hope Research Development

Whittier, California, 90603, United States

Location

Synexus Clinical Research US, Inc. - Colorado Springs Family Practice

Colorado Springs, Colorado, 80909, United States

Location

Gastroenterology Associates of Fairfield County, P.C.

Bridgeport, Connecticut, 06824, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, 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

Palmetto Research, LLC

Hialeah, Florida, 33016, United States

Location

Vida Clinical Trials

Homestead, Florida, 33030, United States

Location

Sanchez Clinical Research, Inc.

Miami, Florida, 33157, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Synexus

Pinellas Park, Florida, 33781, 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, LLC

Buford, Georgia, 30519, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Clinical Research Consultants of Atlanta

Suwanee, Georgia, 30024, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center, PA

Idaho Falls, Idaho, 83404-7596, United States

Location

Synexus Clinical Research US, Inc.

Chicago, Illinois, 60602, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

American Research, LLC

Jeffersonville, Indiana, 47130, United States

Location

Gastroenterology of Southern Indiana

New Albany, Indiana, 47150, United States

Location

Health Science Research Center

Pratt, Kansas, 67124, United States

Location

WestGlen Gastrointestinal Consultants

Shawnee Mission, Kansas, 67214, United States

Location

Kansas Medical Clinic

Topeka, Kansas, 66606, United States

Location

Professional Research Network of Kansas, LLC

Wichita, Kansas, 67205, United States

Location

Via Christi Clinic, PA

Wichita, Kansas, 67208, United States

Location

Tri-State Gastroenterology

Crestview Hills, Kentucky, 41017, United States

Location

WK Physicians Network

Bossier City, Louisiana, 71111, United States

Location

Avant Research Associates LLC

Crowley, Louisiana, 70526, United States

Location

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Clinical Trials of America, Inc.

West Monroe, Louisiana, 71291, United States

Location

Trialspark - Sood

Bowie, Maryland, 20716, United States

Location

Capital Diabetes and Endocrine Associates

Camp Springs, Maryland, 20746, United States

Location

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Woodholme Gastroenterology Associates, P.A.

Glen Burnie, Maryland, 21061, United States

Location

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Meridian Clinical Research, LLC

Rockville, Maryland, 20854, United States

Location

Commonwealth Clinical Studies, PLLC.

Brockton, Massachusetts, 02302, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Synexus Clinical Research US, Inc

St Louis, Missouri, 63141, United States

Location

Heartland Clinical Research, Inc

Omaha, Nebraska, 68134, United States

Location

USMA Clinical Research, LLC

Elizabeth, New Jersey, 07201, United States

Location

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States

Location

Synexus Clinical Research US, Inc.

Jamaica, New York, 11432, United States

Location

Winthrop-University Hospital

Mineola, New York, 11501, United States

Location

Carolina Digestive Health Associates, PA

Davidson, North Carolina, 28036, United States

Location

Kinston Medical Specialists, P.A.

Kinston, North Carolina, 28501, United States

Location

Diabetes and Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, 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

Synexus Clinical Research US, Inc.

Akron, Ohio, 44311, United States

Location

Diabetes & Endocrinology Associates of Stark County, Inc.

Canton, Ohio, 44718, United States

Location

Synexus Clinical Research US - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

Synexus Clinical Research US, Inc

Cincinnati, Ohio, 45249, United States

Location

The MetroHealth System MHS

Cleveland, Ohio, 44109-1998, United States

Location

Digestive Disease & Surgery Institute

Cleveland, Ohio, 44195, 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

CIC America Clinical Inquest Center Ltd.

Dayton, Ohio, 45409, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45424, United States

Location

Centennial Health-Synexus

Oklahoma City, Oklahoma, 73111, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Guthrie Clinical Research

Sayre, Pennsylvania, 18840, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Care Access Research

Warwick, Rhode Island, 02886, United States

Location

Synexus Clinical Research US, Inc.

Anderson, South Carolina, 29621, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, 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

East Tennessee Research Institute

Johnson City, Tennessee, 37604, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

ClinRx Research, LLC

Carrollton, Texas, 75007, 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

Houston Endoscopy and Research Center, Inc.

Houston, Texas, 77079, United States

Location

Rodriguez Clinical Trials

Houston, Texas, 77083, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Pinnacle Clinical Research

San Antonio, Texas, 78215, United States

Location

Synexus Clinical Research US, Inc.

San Antonio, Texas, 78229, United States

Location

Digestive & Liver Disease Center of San Antonio, PLLC

San Antonio, Texas, 78233, United States

Location

Dwayne O. Williams MD

Sugar Land, Texas, 77479, 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

Washington Gastroenterology PLLC

Tacoma, Washington, 98405, 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

Centro de Investigaciones Medicas Mar del Plata SRL

Mar del Plata, Buenos Aires, B7600FYK, Argentina

Location

Instituto Privado de Investigaciones Clínicas de Córdoba

Córdoba, Córdoba Province, X5000AAW, Argentina

Location

Instituto de Investigaciones Clinicas de Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

Rosario, Santa Fe Province, S200CFK, Argentina

Location

Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

CIPREC

Buenos Aires, 1119, Argentina

Location

Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, W3410AVV, Argentina

Location

CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian

Córdoba, X5000BNB, Argentina

Location

Ordination

Sankt Stefan, Styria, 8511, Austria

Location

VIVIT Institute, am LKH Feldkirch

Feldkirch, Vorarlberg, 6807, Austria

Location

Privatklinik Wehrle-Diakonissen

Salzburg, 5020, Austria

Location

Oö. Gesundheits- und Spitals-AG/LKH Steyr

Steyr, 4400, Austria

Location

AZ Sint Lucas Brugge

Bruges, Antwerpen, 2650, Belgium

Location

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

Edegem, Antwerp, 2650, Belgium

Location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Hospital Universitario Walter Cantidio

Fortaleza, Ceará, 60430-372, Brazil

Location

Centro de Pesquisa Clinica do Brasil

Brasília, Federal District, 71625175, Brazil

Location

Hospital Universitario Joao de Barros Barreto

Belém, Pará, 66073-000, Brazil

Location

Núcleo de Pesquisa Clínica do Rio Grande do Sul

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

Location

Instituto Catarinense de Endocrinologia e Diabetes (ICED)

Joinville, Santa Catarina, 89201-260, Brazil

Location

Scentryphar Pesquisa Clinica Ltda

Campinas, São Paulo, 13020-431, Brazil

Location

Instituto de Pesquisa Clinica em Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

CPQuali Pesquisa Clinica Ltda

Santa Cecília, São Paulo, 01228-000, Brazil

Location

Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology

Fortaleza, 60160-230, Brazil

Location

Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda

São Paulo, 01223-001, Brazil

Location

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2E1, Canada

Location

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z1M9, Canada

Location

Eastern Health

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

Location

South Shore Medical Arts

Bridgewater, Nova Scotia, B4V 2V6, 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

Toronto Digestive Disease Associates

Vaughan, Ontario, L4L 4YZ, 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

Centro Cardiovascular Colombiano Clínica Santa María

Medellín, Antioquia, 050034, Colombia

Location

Rodrigo Botero S.A.S.

Medellín, Antioquia, 50030, Colombia

Location

Centro Cardiovascular y de Diabetes

Barranquilla, Atlántico, 080020, Colombia

Location

Fundacion Bios

Barranquilla, Atlántico, 080020, Colombia

Location

Medplus Mp

Bogotá, Bogota D.C., 110221, Colombia

Location

Endocare Ltda.

Bogotá, Bogota D.C., 111111, Colombia

Location

Asociación Colombiana de Diabetes

Bogotá, Cundinamarca, 111311, Colombia

Location

Healthy Medical Center

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Fundacion Centro de Investigaciones Clinicas CARDIOMET

Pereira, Risaralda Department, 660002, Colombia

Location

IPS Centro Medico Julian Coronel S.A

Cali, Valle del Cauca Department, 760035, Colombia

Location

Centro Medico Imbanaco de Cali S.A.

Cali, Valle del Cauca Department, 760042, Colombia

Location

Gastroenheden, Hvidovre hospital

Hvidovre, Copenhagen, 2605, Denmark

Location

Endocrinology, Aalborg University Hospital

Aalborg, DK-9000, Denmark

Location

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Baden-SWürttemberg, 76199, Germany

Location

Studienzentrum Schwittay

Böhlen, Saxony, 4564, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 1309, Germany

Location

Clinical Research Unit

Giessen, 32392, Germany

Location

Clinical Research Hamburg

Hamburg, 22143, Germany

Location

Israelitisches Krankenhaus

Hamburg, 22297, Germany

Location

KRH Klinikum Siloah

Hanover, 30459, Germany

Location

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Heves County, H-3300, Hungary

Location

BKS Research Kft Synexus AS

Hatvan, Heves County, 3000, Hungary

Location

Hetenyi Geza Hospital

Szolnok, Jász-Nagykun-Szolnok, H-5004, Hungary

Location

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Zala County, H-8900, Hungary

Location

Synexus Budapest DRS

Budapest, 1036, Hungary

Location

Strázsahegy Gyógyszertár Medicina

Budapest, H1171, Hungary

Location

SYNEXUS Magyarorszag Kft Debrecen A.S.

Debrecen, 4025, Hungary

Location

Synexus Magyarország kft. Gyula DRS

Gyula, 5700, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, H-6720, Hungary

Location

Synexus Magyarorszag Kft

Zalaegerszeg, 8900, Hungary

Location

Polana-D

Daugavpils, 5401, Latvia

Location

Kraslava Hospital

Krāslava, 5601, Latvia

Location

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

Riga, 1002, Latvia

Location

Digestive Diseases Centre GASTRO

Riga, 1006, Latvia

Location

Unidad de Investigacion Clinica Cardiometabolica de Occidente

Guadalajara, Jalisco, 44150, Mexico

Location

Consultorio Medico

Guadalajara, Jalisco, C.P. 44210, Mexico

Location

Unidad de Investigación Clínica en Medicina S.C.

Guadalajara, Jalisco, C.P. 44670, Mexico

Location

Medical and Nutritional Trials

Cuauhtémoc, Mexico City, 06700, Mexico

Location

Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology

Mexico City, Mexico City, 11650, Mexico

Location

Centro de Atención e Investigación en Factores de Riesgo Car

Mexico City, Mexico City, 14000, Mexico

Location

Clinicos Asociados BOCM SC

Portales, Mexico City, 03300, Mexico

Location

Centro de Desarrollo Biomedico S.C.P.

Mérida, Yucatán, 97070, Mexico

Location

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

Aguascalientes, 20230, Mexico

Location

Hospital Cardiologica Aguascalientes

Aguascalientes, 20230, Mexico

Location

Dioderm Instituto de Investigacion

Durango, 34060, Mexico

Location

Sociedad de Metabolismo y Corazon, S.C.

Veracruz, C.P. 91900, Mexico

Location

Saint-Petersburg City Pokrovskaya Hospital

St-Petersburg, Leningradskaya Oblast', 199106, Russia

Location

Scientific Institute of Clinical and Experimental Lymphology

Novosibirsk, Novosibirsk Oblast, 630117, Russia

Location

GUZ Saratov City Clinical Hospital 9

Saratov, Saratov Oblast, 410030, Russia

Location

Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

Nizhny Novgorod, Volga, 603126, Russia

Location

Kazan State Medical University

Kazan', 420012, 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

Rostov on Don

Rostov-on-Don, 344019, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

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

Saint Petersburg, 191015, Russia

Location

Saratov City Clinical Hospital 12

Saratov, 410039, Russia

Location

FARMOVS

Bloemfontein, Free State, 9301, South Africa

Location

Wits Clinical Research

Johannesburg, Gauteng, 2193, South Africa

Location

Synexus Stanza Clinical Research Centre

Pretoria, Gauteng, 0122, South Africa

Location

Watermeyer Clinical Research Site

Silverton, Gauteng, 184, South Africa

Location

Synexus Helderberg Clinical Research Centre

Cape Town, Western Cape, 7130, South Africa

Location

TREAD Research

Cape Town, 7500, South Africa

Location

MAC Clinical Research Manchester

Manchester, Greater Manchester, M13 9NQ, United Kingdom

Location

Synexus Lancashire Dedicated Research Centre

Chorley, Lancashire, PR7 7NA, United Kingdom

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

Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

MAC Clinical Research, Monarch House

Leeds, West Yorkshire, LS10 1DU, United Kingdom

Location

MAC Research

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research

Blackpool, FY2 0JH, United Kingdom

Location

Synexus Wales Clinical Research Centre

Cardiff, CF15 9SS, United Kingdom

Location

Mid Essex Hospital Services NHS Trust Broomfield Hospital

Chelmsford, CM1 7ET, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Synexus Merseyside Dedicated Research Centre

Liverpool, L22 0LG, United Kingdom

Location

MAC Clinical Research

Liverpool, L34 1BH, United Kingdom

Location

Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital

London, E1 2AJ, United Kingdom

Location

MAC Clinical Research, GAC House

Manchester, M13 9NQ, United Kingdom

Location

Synexus Manchester Clinical Research Centre

Manchester, M15 6SX, United Kingdom

Location

Royal Victoria Infirmary: Clinical Research Facility

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Biomedical Research Centre

Nottingham, NG7 2UH, United Kingdom

Location

Synexus Hexham Dedicated Research Centre

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Synexus North Tees Clinical Research Centre

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

relamorelin

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Wieslaw (Wes) Bochenek, MD, PhD

  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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: February 16, 2018
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (10); LA (4); CA (14); US (114); HU (10); GB (21); CO (11); AU (4); DK (3); RU (11); AR (10); BE (3); ME (12); ZA (6); DE (7)