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Clinical Trial Details

Trial ID: L3182
Source ID: NCT02357420
Associated Drug: Relamorelin
Title: Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02357420/results
Conditions: Diabetes Mellitus|Diabetes Mellitus Complications|Gastroparesis
Interventions: DRUG: Relamorelin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline to Week 12 in Weekly Vomiting Episodes, Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement., 7 days prior to Day 1 for Baseline to 7 days prior to Week 12 | Secondary: Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain), The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement., 7 days prior to Day 1 for Baseline to 7 days prior to Week 12|Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time, GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement., Baseline (Day 1) to Week 12
Sponsor/Collaborators: Sponsor: Allergan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 393
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-01-29
Completion Date: 2016-06-09
Results First Posted: 2019-07-24
Last Update Posted: 2019-07-24
Locations: Digestive Health Specialist of the Southeast, Dothan, Alabama, 36305, United States|Huntsville, Alabama, 35801, United States|Desert Sun Clinical Research, Tucson, Arizona, 85710, United States|Adobe Clinical Research, Tucson, Arizona, 85712, United States|Harrisburg Family Medical Center, Harrisburg, Arkansas, 72432, United States|Arkansas Primary Care Clinic, Little Rock, Arkansas, 72204, United States|Preferred Research Partners, Inc., Little Rock, Arkansas, 72211, United States|TriWest Research Associates, El Cajon, California, 92020, United States|Torrance Clinical Research Institute Inc., Lomita, California, 90717, United States|Axis Clinical Trials, Los Angeles, California, 90036, United States|Inland Empire Liver Foundation, Rialto, California, 92377, United States|Syrentis Clinical Research, Santa Ana, California, 92705, United States|Ventura Clinical Trials, Ventura, California, 93003, United States|Danbury Hospital- Office of Clinical trials, Danbury, Connecticut, 06810, United States|Avail Clinical Research, DeLand, Florida, 32720, United States|International Research Associates LLC, Hialeah, Florida, 33012, United States|Nature Coast Clinical Research, Inverness, Florida, 34452, United States|APF Research, LLC, Miami, Florida, 33135, United States|Advanced Pharma CR, LLC, Miami, Florida, 33136, United States|Baptist Diabetes Associates, P.A., Miami, Florida, 33156, United States|Miami, Florida, 33175, United States|International Research Associates LLC, Miami, Florida, 33183, United States|Advanced Research Institute Inc, New Port Richey, Florida, 34655, United States|Advanced Medical Research Center, Port Orange, Florida, 32127, United States|Palm Beach Research Center, West Palm Beach, Florida, 33409, United States|River Birch Research Alliance LLC, Blue Ridge, Georgia, 30513, United States|Rockford Gastroenterology Associates, Ltd., Rockford, Illinois, 61107, United States|Medisphere Medical Research Center, Evansville, Indiana, 47714, United States|Professional Research Network of Kansas, LLC, Wichita, Kansas, 67203, United States|University of Louisville, Louisville, Kentucky, 40202, United States|Delta Research Partners, Monroe, Louisiana, 71201, United States|Clinical Trials of America LA, LLC, West Monroe, Louisiana, 71291, United States|Metropolitan Gastroenterology Group, P.C. (Chevy Chase Clinical Research) Chevy Chase Clinical Research, Chevy Chase, Maryland, 20815, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Ann Arbor, Michigan, 48109, United States|Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, 48047, United States|Detroit Clinical Research Center, PC-Farmington Hills, Farmington Hills, Michigan, 48334, United States|Center For Digestive Health, Troy, Michigan, 48098, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Planters Clinic, Port Gibson, Mississippi, 39150, United States|Impact Clinical Trials, Las Vegas, Nevada, 89106, United States|Advanced Biomedical Research of America, Las Vegas, Nevada, 89123, United States|Great Neck, New York, 11023, United States|New York Clinical Trials, Inc, New York, New York, 10018, United States|Cumberland Research Associates, LLC, Fayetteville, North Carolina, 28304, United States|OnSite Clinical Solutions- Lexington OnSite Clinical Solutions, LLC, Lexington, North Carolina, 27292, United States|Diabetes and Endocrinology Consultants, P.C., Morehead City, North Carolina, 28557, United States|OnSite Clinical Solutions, LLC, Statesville, North Carolina, 28117, United States|Trial Management Associates, LLC, Wilmington, North Carolina, 28403, United States|Wake Forest University Baptist Health - Dept of Gastroenterology Medical Center Blvd, Winston-Salem, North Carolina, 27107, United States|Consultants for Clinical Research, Cincinnati, Ohio, 45219, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|MetroHealth Medical Center, Leveland, Ohio, 44109, United States|Great Lakes Gastroenterology Research, Mentor, Ohio, 44060, United States|Northwest Gastroenterology Clinic, Portland, Oregon, 97210, United States|Family Medicine of SayeBrook, Myrtle Beach, South Carolina, 29588, United States|ClinSearch LLC, Chattanooga, Tennessee, 37421, United States|El Paso, Texas, 79905, United States|GI Specialists of Houston, Houston, Texas, 77015, United States|Houston Methodist Hospital, Houston, Texas, 77030, United States|The University of Texas Health Science Center & Medical School at Houston, Houston, Texas, 77030, United States|Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States|Gulf Coast Medical Research, LLC, Sugar Land, Texas, 77478, United States|Aspen Clinical Research, Orem, Utah, 84058, United States|Highland Clinical Research, Salt Lake City, Utah, 84095, United States|Gastroenterology Associates of Tidewater, Chesapeake, Virginia, 23320, United States|Khan and Abbasi Research, Chester, Virginia, 23831, United States|Healing Hands of Virginia LLC, Richmond, Virginia, 23225, United States|Gastroenterology Consultants, Virginia Beach, Virginia, 23455, United States|ZainResearch, LLC, Richland, Washington, 99352, United States|Hopital Erasme - Universite Libre de Bruxelles, Brussels, 1070, Belgium|UZ Leuven, Leuven, 3000, Belgium|Herz und Diabeteszentrum Nordrhein Westfalen, Universitätsklinikum der Ruhr-Universiät Bochum, Bad Oeynhausen, 32545, Germany|Praxis Dr. Ott Rabenauer Str., Dippoldiswalde, 01744, Germany|GWT-TUD GmbH, Dresden, 01307, Germany|Israelitisches Krankenhaus Orchideenstig, Hamburg, 22297, Germany|Diabetes Zentrum und Praxis Prof. Pfützner Parcusstr., Mainz, 55116, Germany|Rambam Health Care Campus - Inst. of Endocrinology, Diabetes, and Metabolism, Haifa, 31096, Israel|Wolfson Medical Center, Holon, 58100, Israel|Rabin Medical Center, Beilinson Hospital Gastroenterology Dept, Petach Tikva, 49100, Israel|ZIV Medical Center, Safed, 13100, Israel|Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J. ul., Bialystok, 15-879, Poland|NZOZ Witamed al., Kielce, 25-035, Poland|CenterMed Krakow, Krakow, 31530, Poland|Gabinet Lekarski dr n.med. Malgorzata Saryusz-Wolska ul., Lodz, 90-132, Poland|NZOZ Pulsmedica ul., Lodz, 93-509, Poland|KO-MED Centra Kliniczne, Staszów, 28-200, Poland|Centrum Badawcze Wspólczesnej Terapii ul., Warszawa, 02-679, Poland|Warszawa, 02-679, Poland|Gastroenterology Karolinska University Hospital Karolinska Universitetssjukhuset Gastro Centrum Medicine, Stockholm, 141 86, Sweden|Uppsala University Hospital Gastroenterology / Mag-Tarmmottagningen ingang, Uppsala, SE-751 85, Sweden|NHS Tayside, Dundee, Scotland, DD1 9SY, United Kingdom|Wansbeck General Hospital (Northumbria NHS Trust), Ashington, NE63 9JJ, United Kingdom|University Hospital of North Durham University Hospital of North Durham Research and Development Directorate, Durham, DH1 5TW, United Kingdom|Royal Liverpool University Hospital, Liverpool, L7 8XP, United Kingdom|King's College Hospital, London, SE5 9RS, United Kingdom|The James Cook University Hospital, Middlesbrough, TS4 3BW, United Kingdom|Tyne And Wear, NE29 8NH, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02357420

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress