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 04
A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
2 other identifiers
interventional
450
26 countries
346
Brief Summary
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
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 Feb 2018
Typical duration for phase_3
346 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
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedResults Posted
Study results publicly available
November 23, 2021
CompletedNovember 23, 2021
November 1, 2021
2.8 years
December 19, 2017
October 5, 2021
November 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 of the previous study or the run-in period of this study for new participants.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study
Change From Baseline to Week 52 in the Weekly Average DGSSS
Participants assessed the severity of diabetic gastroparesis symptoms daily using the 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). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
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.
First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
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 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Up to 52 weeks
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 52 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Up to 52 weeks
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
Up to 52 weeks
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Relamorelin 10 μg
EXPERIMENTALRelamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Interventions
Eligibility Criteria
You may qualify if:
- Two different groups of participants may enter into the study:
- Rollover Participants
- Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
- In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
- They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
- They had vomiting episodes and an average daily DGSSS of ≥12 but \<16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
- De Novo Participants
- Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
- DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
- Compliance with the entry of data into the hand-held electronic device during the Run-in Period
- Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
- The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12
You may not qualify if:
- Both Rollover and De Novo Participants
- Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
- Rollover Participants
- De Novo Participants
- History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
- History of intestinal malabsorption or pancreatic exocrine insufficiency
- History of belching disorders, other nausea and vomiting disorders
- Gastric or duodenal ulcer within 3 months of Screening
- History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
- Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
- Currently taking opiates, or expecting to use opiates during the course of the clinical study
- Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
- History of pyloric injection of botulinum toxin within 6 months of screening
- Randomization in any previous study in which relamorelin was a treatment
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (349)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
North Alabama Research Center, LLC
Athens, Alabama, 35611, United States
Simon Williamson Clinic
Birmingham, Alabama, 35211, United States
Digestive Health Specialist of the South East
Dothan, Alabama, 36305, United States
G & L Research, LLC
Foley, Alabama, 36535, United States
Avant Research Associates
Huntsville, Alabama, 35801, United States
Alabama Medical Group, PC
Mobile, Alabama, 36608, United States
Phoenix Clinical LLC.
Phoenix, Arizona, 85014, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85710, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85712, United States
Synexus Clinical Research US, Inc.
Tucson, Arizona, 85741, 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
TriWest Research Associates
El Cajon, California, 92020, 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, 90057, United States
Stanford Hospital
Palo Alto, California, 94304, United States
Optimal Research California
San Diego, California, 92108, 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
Synexus Clinical Research US, Inc.
Vista, California, 92083, United States
New Hope Research Development
Whittier, California, 90603, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Synexus
Colorado Springs, Colorado, 80909, United States
Gastroenterology Associates of Fairfield County, P.C.
Bridgeport, Connecticut, 06606, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Innovative Research of West FL, Inc.
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
Savin Medical Group LLC
Miami Lakes, Florida, 33014, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Synexus
Pinellas Park, Florida, 33781, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, 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
North Shore University Health System
Evanston, Illinois, 60201, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Synexus Clinical Research US, Inc.
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, 66217, 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
St. Elizabeth Healthcare â€" Clinical Research Institute
Erlanger, Kentucky, 41018, United States
University of Louisville
Louisville, Kentucky, 40202, 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
Clinical Trials of America, Inc.
West Monroe, Louisiana, 71291, United States
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, 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
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Meridian Clinical Research, LLC
Rockville, Maryland, 20854, 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, West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
MNGI Digestive Health
Coon Rapids, Minnesota, 55446, United States
Synexus Clinical Research US, Inc.
Richfield, Minnesota, 55423, United States
Synexus Clinical Research US, Inc
St Louis, Missouri, 63141, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Diabetes and Endocrine Associates, P.C.
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 - CROSN
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, 89135, United States
Garden State Endocrinology LLC
Brick, New Jersey, 08723, United States
Synexus Clinical Research US, Inc.
Bridgeton, New Jersey, 08302, 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
United Health Services Hospitals, Inc.
Johnson City, New York, 13790, United States
CHEAR Center LLC
The Bronx, New York, 10455, 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
Carolinas Healthcare-Charlotte
Charlotte, North Carolina, 28204, 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
Synexus Clinical Research US, Inc.
Akron, Ohio, 44311, 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
Synexus Clinical Research US, Inc
Cincinnati, Ohio, 45249, 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.
Wadsworth, Ohio, 44281, United States
Centennial Health-Synexus
Oklahoma City, Oklahoma, 73111, 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
Guthrie Clinical Research
Sayre, Pennsylvania, 18840, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research, LLC
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
Carolina Medical Research
Clinton, South Carolina, 29325, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29615, United States
Synexus Clinical Research
Greer, South Carolina, 29650, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Clinsearch
Chattanooga, Tennessee, 37421, United States
Gastroenterology Centers of the Midsouth
Germantown, Tennessee, 38138, United States
East Tennessee Research Institute
Johnson City, Tennessee, 37604, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
DiscoveResearch, Inc.
Beaumont, Texas, 77701, United States
ClinRx Research, LLC
Carrollton, Texas, 75007, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Biopharma Informatic Inc., Research Center
Houston, Texas, 77043, United States
Houston Endoscopy and Research Center, Inc.
Houston, Texas, 77079, United States
Rodriguez Clinical Trials
Houston, Texas, 77083, United States
Amir 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
Sagact Pllc.
San Antonio, Texas, 78229, United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229, United States
Synexus Clinical Research US, Inc.
Layton, Utah, 84041, United States
Synexus Clinical Research US, Inc.
Murray, Utah, 84123, 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
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Manassas Clinical Research Centre
Manassas, Virginia, 20110, United States
VA Medical Center McGuire VAMC
Richmond, Virginia, 23249, United States
Washington Gastroenterology PLLC
Tacoma, Washington, 98405, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Consultorios Asociados de Endocrinologia e Investigación Cl
Buenos Aires, Buenos Aires, C1425AGC, Argentina
Hospital Sirio Libanes
CABA, Buenos Aires, C1419AHN, Argentina
Centro de Investigaciones Medicas Mar del Plata SRL
Mar del Plata, Buenos Aires, B7600FYK, Argentina
CIPREC
Buenos Aires, Ciudad Autonoma deBuenos Aires, 1119, Argentina
Instituto de Investigaciones Clinicas de Rosario
Rosario, Santa Fe Province, S2000BIE, Argentina
Instituto Medico Catamarca-I.ME.C
Rosario, Santa Fe Province, S200CFK, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro Universitario de Investigacion en Farmacologia Clinic
Corrientes, W3410AVV, Argentina
Instituto Privado de Investigaciones Clinicas de Cordoba
Córdoba, X5000AAW, Argentina
CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
Córdoba, X5000BNB, Argentina
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
Adelaide, South Australia, 5000, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Ordination
Osterreicher, Styria, 8511, Austria
VIVIT Institute, am LKH Feldkirch
Feldkirch, Vorarlberg, 6807, Austria
Privatklinik wehlre-Diakonissen
Salzburg, 5020, Austria
Oö. Gesundheits- und Spitals-AG/LKH 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
Hospital Universitário Walter Cantídio
Fortaleza, Ceará, 60430-270, Brazil
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, 71625175, Brazil
Hospital Universitário João de Barros Barreto - UFPA
Belém, Pará, 66073-005, 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 Clínica Ltda
Campinas, São Paulo, 13020-431, Brazil
Instituto de Pesquisa Clinica em Campinas
Campinas, São Paulo, 13060-080, Brazil
Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology
Fortaleza, 60160-230, Brazil
IPEC-Instituto de Pesquisa Clinica
São Paulo, 01223-001, Brazil
CPQuali Pesquisa Clinica Ltda
São Paulo, 01228-000, Brazil
MHAT Yuliya Vrevska Byala
Byala, Ruse, 7100, Bulgaria
UMHAT - Kaspela- EOOD
Plovdiv, 4002, Bulgaria
Medical Center Asklepion - Humane Medicine Research EOOD
Sofia, 1303, Bulgaria
Alexandrovska University Hospital
Sofia, 1431, Bulgaria
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Central Alberta Research Centre
Red Deer, Alberta, T4N 6V7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Patient research centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
South Shore Medical Arts
Bridgewater, Nova Scotia, B4V 3N2, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, 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
Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS
Barranquilla, Atlántico, 080020, Colombia
Medplus Centro de Recuperacion Integral S.A.S.
Bogotá, Bogota D.C., 110221, Colombia
Endocare Ltda.
Bogotá, Bogota D.C., 111111, Colombia
Asociación Colombiana de Diabetes
Bogotá, Cundinamarca, 111311, Colombia
Healthy Medical Center
Zipaquirá, Cundinamarca, 250252, Colombia
Centro de Investigaciones Clínicas IPS CARDIOMET Pereira
Pereira, Risaralda Department, 660003, Colombia
IPS Centro Medico Julian Coronel S.A
Cali, Valle del Cauca Department, 760035, Colombia
Centro Medico Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, 760042, Colombia
Steno Diabetes Center Copenhagen
Hellerup, Copenhagen, 2900, Denmark
Gastroenheden, Hvidovre hospital
Hvidovre, København, 2605, Denmark
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-Wurttemberg, 76199, 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
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Heves County, H-3300, Hungary
Hetenyi Geza Hospital
Szolnok, Jász-Nagykun-Szolnok, H-5004, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Zala County, H-8900, Hungary
Strázsahegy Gyógyszertár Medicina
Budapest, H1171, Hungary
Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika
Szeged, H-6720, 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 - Gasterentrology
Ahmedabad, Gujarat, 380007, India
Zydus Hospital
Ahmedabad, Gujarat, 380054, India
Lifecare Clinic and Research Centre - Internal Med/Diabetology
Bangalore, Karnataka, 560092, India
Diacon Hospital and research Center - Diabetology
Bengaluru, Karnataka, 359-360, India
Victoria Hospital Bangalore Medical College and Research Institute
Bengaluru, Karnataka, 560002, India
Rajalakshmi Hospital
Bengaluru, Karnataka, 560097, 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
Marudhar Hospital
Jaipur, Rajasthan, 302012, India
Eternal Hospital - Diabetology
Jaipur, Rajasthan, 302017, India
SMS Hospital
Jaipur, Rajasthan, 302017, India
M.V. Hospital for Diabetes & Diabetes Research Centre
Chennai, Tamil Nadu, 600013, 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 Pradesh, 226003, India
Sir Ganga Ram Hospital (SGRH)
Delhi, 110060, India
Vinaya Hospital & Research Centre
Mangalore, 575003, India
Bnei-Zion MC
Haifa, 31948, 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
Clinical Investigation Centre
Kuala Lumpur, 59100, Malaysia
Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia
Kubang Kerian, 16150, Malaysia
Hospital Taiping
Taiping, 34000, Malaysia
Unidad de Investigacion Clinica Cardiometabolica de Occidente
Guadalajara, Jalisco, 44150, Mexico
Consultorio particular
Guadalajara, Jalisco, 44210, Mexico
Unidad de Investigación Clínica en Medicina S.C/
Guadalajara, Jalisco, 44670, Mexico
Clinicos Asociados BOCM SC
Mexico City, Mexico City, 03300, Mexico
Mentrials Sa de Cv
Mexico City, Mexico City, 06700, 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
Mexico City, Mexico City, 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
CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
Durango, 34270, 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
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
St. Luke's Medical Center
Quezon City, 1100, Philippines
Specjalistyczny Gabinet Neurologiczny Marta Banach
Krakow, Lesser Poland Voivodeship, 30-539, Poland
CenterMed Krakow Ltd
Krakow, Malopolska, 31-530, Poland
Centrum Medyczne Lukamed
Chojnice, 89-600, Poland
Saint-Petersburg City Pokrovskaya Hospital
St-Petersburg, Leningradskaya Oblast', 199106, Russia
GUZ Saratov City Clinical Hospital 9
Saratov, Saratov Oblast, 410030, Russia
Scientific Institute of Clinical and Experimental Lymphology
Novosibirsk, 630117, Russia
Rostov on Don
Rostov-on-Don, 344019, Russia
National University Hospital
Singapore, 119228, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Singapore General Hospital
Singapore, S169856, Singapore
FARMOVS
Bloemfontein, Free State, 9301, South Africa
Wits Clinical Research
Johannesburg, Gauteng, 2193, South Africa
Synexus Stanza Clinical Research Centre
Pretoria, Gauteng, 0122, South Africa
Watermeyer Clinical Research Site
Pretoria, Val de Grace, 0184, South Africa
Synexus Helderberg Clinical Research Centre
Somerset West, 7130, South Africa
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712, South Korea
Sanggye Paik Hospital, Inje University College of Medicine
Seoul, Nowon-gu, 1757, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Universitario Principe de Asturias
Madrid, 28850, Spain
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
Dnipro, Dnipropetrovsk Oblast, 49027, Ukraine
Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia
Zaporizhzhia, Zaporizhzhia Oblast, 69600, Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58001, Ukraine
Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo
Chernivtsi, 58022, Ukraine
Ivano-Frankivsk National Medical University
Ivano-Frankivsk, 76008, Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, 76018, Ukraine
Municipal nonprofit entity of Kharkiv municipal council
Kharkiv, 61037, 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
Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department
Kyiv, 3049, 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
Poltava Regional Clinical Hospital
Poltava, 36011, Ukraine
Private Small-Scale Enterprise Medical Centre Pulse
Vinnytsia, 21001, Ukraine
Vinnytsia Regional Clinical highly specialized Endocrinology Centre
Vinnytsia, 21010, Ukraine
Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology
Zaporizhzhia, 69035, 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 Clinical Research
Liverpool, Merseyside, L34 1BH, United Kingdom
MAC Research, Exchange House
Cannock, Staffordshire, WS11 0BH, United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, ST6 8DG, 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, GAC House
Manchester, M13 9NQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Harvy Schneier
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
December 19, 2017
First Posted
December 26, 2017
Study Start
February 1, 2018
Primary Completion
November 5, 2020
Study Completion
November 5, 2020
Last Updated
November 23, 2021
Results First Posted
November 23, 2021
Record last verified: 2021-11