Study Stopped
The Relamorelin program is being terminated solely based on a business decision.
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
1 other identifier
interventional
467
25 countries
333
Brief Summary
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2018
Typical duration for phase_3
333 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedStudy Start
First participant enrolled
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedResults Posted
Study results publicly available
December 22, 2021
CompletedDecember 22, 2021
November 1, 2021
2.8 years
January 24, 2018
October 5, 2021
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
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 in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-week Treatment Period.
Week 6 to Week 12
Secondary Outcomes (15)
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
- +10 more secondary outcomes
Study Arms (5)
Treatment Period: Placebo
PLACEBO COMPARATORPlacebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
Treatment Period: Relamorelin 10 μg
EXPERIMENTALRelamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
Randomized Withdrawal Period: Placebo then Relamorelin 10 μg
EXPERIMENTALParticipants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg
EXPERIMENTALParticipants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
Randomized Withdrawal Period: Relamorelin 10 μg then Placebo
EXPERIMENTALParticipants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Interventions
Placebo injected twice daily
Relamorelin 10 μg injected twice daily
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all the following criteria apply:
You may not qualify if:
- Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
- In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02
- Participants are excluded from the study if any of the following criteria apply:
- Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
- Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
- Participant has an unresolved adverse event (AE) or 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (337)
North Alabama Research Center, LLC
Athens, Alabama, 35611, United States
Digestive Health Specialist of the South East
Dothan, Alabama, 36305, United States
G & L Research, LLC
Foley, Alabama, 36535, United States
Alabama Medical Group, PC
Mobile, Alabama, 36608, United States
Del Sol Research Management, LLC
Chandler, Arizona, 85224, United States
Phoenix Clinical LLC.
Phoenix, Arizona, 85014, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85712, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Unity Health - Searcy Medical Center
Searcy, Arkansas, 72143, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
GW Research Inc
Chula Vista, California, 91910, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Aurora Care Clinic, LLC
Costa Mesa, California, 92627, United States
Diagnamics Inc.
Encinitas, California, 92024, United States
VVCRD Research
Garden Grove, California, 92845, United States
University of California San Diego
La Jolla, California, 92037, United States
Om Research LLC
Lancaster, California, 93534, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717, United States
Angel City Research Inc.
Los Angeles, California, 90026, United States
TriWest Research Associates
Poway, California, 92064, United States
Medical Associates Research Group, Inc
San Diego, California, 92123, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Upland Clinical Research
Upland, California, 91786, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
Colorado Springs, Colorado, 80909, United States
Gastroenterology Associates of Fairfield County, P.C.
Bridgeport, Connecticut, 06606, United States
TrialSpark, Inc.
Washington D.C., District of Columbia, 20017, United States
Innovative Research of West FL, Inc.
Clearwater, Florida, 33756, United States
West Central Gastroenterology
Clearwater, Florida, 33756, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
ALL Medical Research LLC
Cooper City, Florida, 33024, United States
Top Medical Research
Cutler Bay, Florida, 33189, United States
Palmetto Research, LLC
Hialeah, Florida, 33016, United States
Vida Clinical Trials
Homestead, Florida, 33030, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
APF Research LLC
Miami, Florida, 33134, United States
AMPM Research Clinic
Miami, Florida, 33169, United States
Advanced Medical Research Institute
Miami, Florida, 33174, United States
Florida Research Center, Inc.
Miami, Florida, 33174, United States
American Research Institute, Inc
Miami, Florida, 33175, United States
Panax Clinical Research, LLC.
Miami Lakes, Florida, 33014, United States
Savin Medical Group LLC
Miami Lakes, Florida, 33014, United States
Synexus
Pinellas Park, Florida, 33781, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Emory University
Atlanta, Georgia, 30322, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Gwinnett Research Institute, LLC
Buford, Georgia, 30519, United States
Summit Clinical Research, LLC.
Carnesville, Georgia, 30521, United States
iResearch Atlanta LLC
Decatur, Georgia, 30030, United States
Infinite Clinical Trials
Riverdale, Georgia, 30274, United States
Clinical Research Consultants of Atlanta
Suwanee, Georgia, 30024, United States
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, 83404-7596, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
American Research, LLC
Jeffersonville, Indiana, 47130, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Health Science Research Center
Pratt, Kansas, 67124, United States
WestGlen Gastrointestinal Consultants
Shawnee Mission, Kansas, 67214, United States
Cotton-O'Neil Clinical Research Center - Digestive Health
Topeka, Kansas, 66606, United States
Kansas Medical Clinic
Topeka, Kansas, 66606, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205, United States
Via Christi Clinic, PA
Wichita, Kansas, 67208, United States
Tri-State Gastroenterology
Crestview Hills, Kentucky, 41017, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Delta Research Partners
Bastrop, Louisiana, 71220, United States
WK Physicians Network
Bossier City, Louisiana, 71111, United States
Avant Research Associates LLC
Crowley, Louisiana, 70526, United States
Cronola LLC
Houma, Louisiana, 70360, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, 70601, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
New Orleans Research Institute - Metropolitan Gastroenterology Associates
Metairie, Louisiana, 70006, United States
Clinical Trials of America, Inc.
West Monroe, Louisiana, 71291, United States
Trialspark - Silverman
Bowie, Maryland, 20716, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Frederick Gastroenterology Associates, PA an Elligo Health Research Site
Frederick, Maryland, 21701, United States
Woodholme Gastroenterology Associates, P.A.
Glen Burnie, Maryland, 21061, United States
Meridian Clinical Research, LLC
Rockville, Maryland, 20854, United States
Commonwealth Clinical Studies, PLLC.
Brockton, Massachusetts, 02302, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047, United States
Vida Clinical Studies
Dearborn, Michigan, 48124, United States
Aa Mrc Llc
Flint, Michigan, 48504, United States
National Clinical, LLC
Hamtramck, Michigan, 48212, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519, United States
Minnesota Gastroenterology, P.A.
Coon Rapids, Minnesota, 55446, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Methodist Physicians Clinic Diabetes and Endocrine Specialists
Omaha, Nebraska, 68114, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Digestive Disease Specialists
Las Vegas, Nevada, 89128, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
Garden State Endocrinology
Brick, New Jersey, 08723, United States
AGA Clinical Research Associates LLC
Egg Harbor, New Jersey, 08234, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, 11023, United States
Synexus Clinical Research US, Inc.
Jamaica, New York, 11432, United States
United Health Services Hospitals, Inc.
Johnson City, New York, 13790, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7080, United States
Carolina Digestive Health Associates, PA
Concord, North Carolina, 28025, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Triad Clinical Trials
Greensboro, North Carolina, 27410, United States
Vidant Multispeciality Clinic - Kinston
Kinston, North Carolina, 28501, United States
Diabetes and Endocrinology Consultants, PC
Morehead City, North Carolina, 28557, United States
PMG Research Salisbury
Salisbury, North Carolina, 28144, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440, United States
Diabetes & Endocrinology Associates of Stark County, Inc.
Canton, Ohio, 44718, United States
Synexus Clinical Research US - Cincinnati
Cincinnati, Ohio, 45236, United States
Endocrinology Research Associates, Inc.
Columbus, Ohio, 43201, United States
The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43203, United States
Aventiv Research, Inc.
Columbus, Ohio, 43213, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, United States
CIC America Clinical Inquest Center Ltd.
Dayton, Ohio, 45409, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Premier Clinical Research d.b.a. STAT Research
Franklin, Ohio, 45005, United States
Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research
Wadsworth, Ohio, 44281, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112, United States
Memorial Clinical Research
Oklahoma City, Oklahoma, 73120, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97210, United States
Family Medical Associates, Research Department
Levittown, Pennsylvania, 19056, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Montgomery Medical, Inc.
Smithfield, Pennsylvania, 15478, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621, United States
Synexus Clinical Research US, Inc
Anderson, South Carolina, 29621, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29615, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Clinsearch
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Avant Research Associates,LLC
Austin, Texas, 78704, United States
ClinRx Research, LLC
Carrollton, Texas, 75007, United States
Synexus Clinical Research US, Inc.
Dallas, Texas, 75234, United States
Biopharma Informatic Inc., Research Center
Houston, Texas, 77043, United States
Rodriguez Clinical Trials
Houston, Texas, 77083, United States
Amir Ali Hassan, MD, PA
Houston, Texas, 77089, United States
Sante Clinical Research
Kerrville, Texas, 78028, United States
Pinnacle Clinical Research
San Antonio, Texas, 78215, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229, United States
Advanced Research Institute, Inc.
Ogden, Utah, 84405, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Verity Research Inc.
Fairfax, Virginia, 22031, United States
Manassas Clinical Research Centre
Manassas, Virginia, 20110, United States
Cardinal Internal Medicine Associates, PC
Woodbridge, Virginia, 22192, United States
Washington Gastroenterology PLLC
Tacoma, Washington, 98405, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Maffei Centro Medico-Investigacion Clinica Aplicada
C.a.b.a., Buenos Aires, C1425AGC, Argentina
Hospital Sirio Libanes
CABA, Buenos Aires, C1419AHN, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK, Argentina
Instituto Privado de Investigaciones Clínicas de Córdoba
Córdoba, Córdoba Province, X5000AAW, Argentina
Instituto de Investigaciones Clinicas de Rosario
Rosario, Santa Fe Province, 2000, Argentina
Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
Rosario, Santa Fe Province, S200CFK, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
CIPREC
Buenos Aires, 1119, Argentina
Centro Universitario de Investigacion en Farmacologia Clinic
Corrientes, W3410AVV, Argentina
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Ordination
Sankt Stefan ob Stainz, Styria, 8511, Austria
VIVIT Institute, am LKH Feldkirch
Feldkirch, Vorarlberg, 6807, Austria
Privatklinik Wehrle-Diakonissen
Salzburg, 5020, Austria
Landeskrankenhaus Steyr
Steyr, 4400, Austria
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
Edegem, Antwerp, 2650, Belgium
UZ Brussel
Jette, Brussels Capital, 1090, Belgium
AZ Sint Lucas Brugge
Bruges, West-Vlaanderen, 8310, Belgium
Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
Fortaleza, Ceará, 60160-230, Brazil
Hospital Universitário Walter Cantídio
Fortaleza, Ceará, 60430-370, Brazil
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, 71625175, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Instituto Catarinense de Endocrinologia e Diabetes (ICED)
Joinville, Santa Catarina, 89201-260, Brazil
Scentryphar Pesquisa Clinica Ltda
Campinas, São Paulo, 13020-431, Brazil
Instituto de Pesquisa Clinica de Campinas
Campinas, São Paulo, 13060904, Brazil
CPQuali Pesquisa Clinica Ltda
Santa Cecília, São Paulo, 01228-000, Brazil
Hospital Universitário João de Barros Barreto
Belém, 66073-000, Brazil
IPEC-Instituto de Pesquisa Clinica
São Paulo, 01223-001, Brazil
MHAT Yuliya Vrevska Byala
Byala, Ruse, 7100, Bulgaria
UMHAT - Kaspela- EOOD
Plovdiv, 4002, Bulgaria
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2E1, Canada
Central Alberta Research Centre
Red Deer, Alberta, T4N 6V7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
South Shore Medical Arts
Bridgewater, Nova Scotia, B4V 2V6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, L4L 4YZ, Canada
Recherche GCP Research
Montreal, Quebec, H1M 1B1, Canada
Rodrigo Botero S.A.S.
Medellín, Antioquia, 050030, Colombia
Centro Cardiovascular Colombiano Clínica Santa María
Medellín, Antioquia, 050034, Colombia
Centro Cardiovascular y de Diabetes
Barranquilla, Atlántico, 080020, Colombia
Fundacion BIOS
Barranquilla, Atlántico, 080020, Colombia
Medplus Medicina Prepagada
Bogotá, Bogota D.C., 110221, Colombia
Asociación Colombiana de Diabetes
Teusaquillo, Bogota D.C., 111311, Colombia
Endocare Ltda.
Bogotá, Cundinamarca, 111111, Colombia
Healthy Medical Center
Zipaquirá, Cundinamarca, 250252, Colombia
Fundacion Centro de Investigaciones Clinicas CARDIOMET
Pereira, Risaralda Department, 660002, Colombia
Centro Medico Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, 760001, Colombia
IPS Centro Medico Julian Coronel S.A
Cali, Valle del Cauca Department, 760035, Colombia
Gentofte Hospital
Hellerup, Copenhagen, 2900, Denmark
Gastroenheden, Hvidovre hospital
Hvidovre, Copenhagen, 2650, Denmark
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-Wurttemberg, 76137, Germany
Studienzentrum Schwittay
Böhlen, Saxony, 4564, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, 1309, Germany
Clinical Research Hamburg
Hamburg, 22143, Germany
Israelitisches Krankenhaus
Hamburg, 22297, Germany
KRH Klinikum Siloah
Hanover, 30459, Germany
First Department of Medicine, University of Szeged
Szeged, Csonfrád, 6720, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Heves County, H-3300, Hungary
Hetenyi Geza Hospital
Tószeg, Jász-Nagykun-Szolnok, H-5004, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Zala County, H-8900, Hungary
Synexus Budapest DRS
Budapest, 1036, Hungary
Strázsahegy Gyógyszertár Medicina
Budapest, H1171, Hungary
Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
Hyderabad, Andhra Pradesh, 500072, India
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002, India
Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre
Ahmedabad, Gujarat, 380007, India
Victoria Hospital
Bangalore, Karnataka, 560002, India
Life Care Hospital & Research Centre
Bangalore, Karnataka, 560092, India
Diacon Hospital and research Center - Diabetology
Bengaluru, Karnataka, 359-360, India
Rajalakshmi Hospital
Bengaluru, Karnataka, 560097, India
Vinaya Hospital & Research Centre
Mangalore, Karnataka, 575003, India
Bhatia Hospital
Mumbai, Maharashtra, 400007, India
B. J. Government Medical College and Sassoon General Hospitals
Pune, Maharashtra, 411001, India
Universal Hospital
Pune, Maharashtra, 411011, India
Noble Hospital
Pune, Maharashtra, 411013, India
S.R. Kalla (SRK) Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
Diabetic Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006, India
Marudhar Hospital
Jaipur, Rajasthan, 302012, India
Eternal Hospital - Diabetology
Jaipur, Rajasthan, 302017, India
SMS Hospital
Jaipur, Rajasthan, 302017, India
Kovai Diabetes Speciality Centre
Coimbatore, Tamil Nadu, 641009, India
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, 625020, India
M. V Hospital & Research Centre
Lucknow, Uttar Prandesh, 226003, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Bnai Zion Medical Center
Haifa, 31048, Israel
Endocrinology & Diabetes Center
Safed, 13100, Israel
Kraslava Hospital
Krāslava, Kraslavas Nov., 5601, Latvia
Polana-D
Daugavpils, LV5401, Latvia
Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
Riga, 1002, Latvia
Digestive Diseases Centre GASTRO
Riga, 1006, Latvia
Hospital Sultanah Bahiyah
Alor Star, Kedah, 5460, Malaysia
Universiti Sains Malaysia
Kubang Kerian, 16150, Malaysia
Hospital Taiping
Taiping, 34000, Malaysia
Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición
Durango, Guillermina, 34270, Mexico
Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.
Guadalajara, Jalisco, 44150, Mexico
Consultorio Medico
Guadalajara, Jalisco, C.P. 44210, Mexico
Unidad de Investigación Clínica en Medicina S.C.
Guadalajara, Jalisco, C.P. 44670, Mexico
Mentrials SA DE CV
Cuauhtémoc, Mexico City, 06700, Mexico
Clinicos Asociados BOCM SC
Mexico City, Mexico City, 03300, Mexico
Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
Mexico City, Mexico City, 11650, Mexico
Centro de Atención e Investigación en Factores de Riesgo Car
México, Mexico DF, 14000, Mexico
Centro de Desarrollo Biomédico S.C.P
Mérida, Yucatán, 97070, Mexico
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
Aguascalientes, 20230, Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230, Mexico
Dioderm Instituto de Investigacion
Durango, 34060, Mexico
Sociedad de Metabolismo y Corazon, S.C.
Veracruz, 91900, Mexico
West Visayas State University Medical Center
Iloilo City, IloIlo, 5000, Philippines
Manila Doctors Hospital, Ermita
Manila, Metropolitan Manila, 1000, Philippines
San Juan De Dios Educational Foundation, Inc.
Pasay, Metropolitan Manila, 1300, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, 1100, Philippines
Cardinal Santos Medical Center
San Juan City, National Capital Region, 1502, Philippines
Ospital ng Makati
Makati City, NCR, 1218, Philippines
Perpetual Succor Hospital
Cebu City, 6000, Philippines
NZOZ Vita Diabetica - Malgorzata Buraczyk
Bialystok, Podlaski, 15-798, Poland
Endoskopia Sp. Z O.O.
Sopot, Pomeranian Voivodeship, 81-756, Poland
Centrum Medyczne Lukamed
Chojnice, 89-600, Poland
Specjalistyczny Gabinet Neurologiczny Marta Banach
Krakow, 30-539, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw, 51-162, Poland
Saint-Petersburg City Pokrovskaya Hospital
St-Petersburg, Leningradskaya Oblast', 199106, Russia
Scientific Institute of Clinical and Experimental Lymphology
Novosibirsk, Novosibirsk Oblast, 630117, Russia
North-Western State Medical University named after I. I. Mechnikov
Saint Petersburg, Sankt-Peterburg, 191015, Russia
Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
Nizhny Novgorod, Volga, 603126, Russia
Kazan State Medical University
Kazan', 420100, Russia
FSBI National medical endocrinology research centre
Moscow, 117036, Russia
Moscow Regional Research Clinical Institute named by MF Vladimirski
Moscow, 129110, Russia
Rostov on Don
Rostov-on-Don, 344019, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
GUZ Saratov City Clinical Hospital 9
Saratov, 410030, Russia
Saratov City Clinical Hospital 12
Saratov, 410039, Russia
National University Hospital
Singapore, 119228, Singapore
Singapore General Hospital
Singapore, 169856, Singapore
Changi General Hospital
Singapore, 529889, Singapore
FARMOVS
Bloemfontein, Free State, 9301, South Africa
Wits Clinical Research
Johannesburg, Gauteng, 2193, South Africa
Synexus Stanza Clincal Reaserch Centre
Pretoria, Gauteng, 0122, South Africa
Watermeyer Clinical Research Site
Pretoria, Gauteng, 0184, South Africa
Synexus Helderberg Clinical Research Centre
Cape Town, Western Cape, 7130, South Africa
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712, South Korea
Diabetes Center
Seoul, Nowon-gu, 01757, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Ivano-Frankivsk National Medical University
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
Regional muniRegional 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
Chernivtsi, 58001, Ukraine
Regional Public Organization "Chernivtsi Regional Endocrinology Center"
Chernivtsi, 58022, Ukraine
State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
Dnipro, 49027, Ukraine
Municipal nonprofit entity of Kharkiv municipal council
Kharkiv, 61037, Ukraine
L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
Kharkiv, 61039, Ukraine
Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
Kharkiv, 61070, Ukraine
Communal Institution Kherson City Clinical Hospital
Kherson, 73000, Ukraine
Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
Kyiv, 2002, Ukraine
Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"
Kyiv, 3049, Ukraine
Medical Center Universal Clinic Oberig
Kyiv, 3057, Ukraine
Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
Kyiv, 4050, Ukraine
Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
Odesa, 65010, Ukraine
Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
Odesa, 65025, Ukraine
Poltava Regional Clinical Hospital
Poltava, 36011, Ukraine
Ternopil University Hospital
Ternopil, 46000, Ukraine
Private Small-Scale Enterprise Medical Centre Pulse
Vinnytsia, 21001, Ukraine
Vinnytsia Regional Clinical highly specialized Endocrinology Centre
Vinnytsia, 21010, Ukraine
Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
Vinnytsia, 21029, Ukraine
6th City Clinical Hospital, c. Zaporizhzhia
Zaporizhzhia, 69035, Ukraine
Municipal Institution, City Hospital #7
Zaporizhzhia, 69600, Ukraine
Biomedical Research Centre
Nottingham, East Midland, NG7 2UH, United Kingdom
MAC Clinical Research Manchester
Manchester, Greater Manchester, M13 9NQ, United Kingdom
Royal Oldham Hospital
Oldham, Lancashire, OL1 2JH, United Kingdom
MAC Research, Exchange House
Cannock, Staffordshire, WS11 0BH, United Kingdom
MAC Clinical Research, Monarch House
Leeds, West Yorkshire, LS10 1DU, United Kingdom
MAC Research
Barnsley, S75 3DL, United Kingdom
MAC Clinical Research, Kaman Court
Blackpool, FY2 0JH, United Kingdom
Mid Essex Hospital Services NHS Trust Broomfield Hospital
Chelmsford, CM1 7ET, United Kingdom
MAC Clinical Research
Liverpool, L34 1BH, United Kingdom
MAC Clinical Research, GAC House
Stockton-on-Tees, TS17 6EW, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Wieslaw Bochenek
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2018
First Posted
February 5, 2018
Study Start
January 24, 2018
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
December 22, 2021
Results First Posted
December 22, 2021
Record last verified: 2021-11