Study Stopped
The Relamorelin program is being terminated solely based on a business decision.
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
A 12-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
336
14 countries
216
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.
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 Sep 2017
Typical duration for phase_3
216 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
September 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2020
CompletedResults Posted
Study results publicly available
July 29, 2021
CompletedJuly 29, 2021
July 1, 2021
2.8 years
September 14, 2017
July 8, 2021
July 8, 2021
Conditions
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
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORFollowing a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Relamorelin 10 μg
EXPERIMENTALFollowing a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (216)
University of Alabama at Birmingham
Birmingham, Alabama, 35295, United States
Digestive Health Specialist of the South East
Dothan, Alabama, 36305, United States
Avant Research Associates
Huntsville, Alabama, 35801, United States
Synexus Clinical Research US, Inc.
Fountain Hills, Arizona, 85268, United States
Central Arizona Medical Associates
Mesa, Arizona, 85206, 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
Arkansas Gastorenterology
North Little Rock, Arkansas, 72117, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Aurora Care Clinic, LLC
Costa Mesa, California, 92627, United States
Citrus Valley Gastroenterology Clinic
Covina, California, 91722, 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
Clinical Applications Laboratories, Inc.
San Diego, California, 92103, United States
Medical Associates Research Group, Inc
San Diego, California, 92123, United States
Synexus Clinical Research, US, Santa Rosa
Santa Rosa, California, 95405, United States
Upland Clinical Research
Upland, California, 91786, United States
Synexus Clinical Research US, Inc.
Vista, California, 92083, United States
University of Colorado, Denver
Aurora, Colorado, 80045, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Denver Esophageal and Stomach Center
Englewood, Colorado, 80110, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, 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
American Research Institute, Inc
Cutler Bay, Florida, 33157, United States
Top Medical Research
Cutler Bay, Florida, 33189, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Cfagi Llc
Maitland, Florida, 32751, 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
Savin Medical Group LLC
Miami Lakes, Florida, 33014, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514, United States
University of South Florida
Tampa, Florida, 33606, United States
West Central Gastroenterology
Tampa, Florida, 33626, United States
Summit Clinical Research, LLC
Carnesville, Georgia, 30521, United States
Infinite Clinical Trials
Riverdale, Georgia, 30274, 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
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, 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
Cotton-O'Neil Clinical Research Center - Digestive Health
Topeka, Kansas, 66606, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Delta Research Partners
Bastrop, Louisiana, 71220, United States
Cronola LLC
Houma, Louisiana, 70360, United States
New Orleans Research Institute - Metropolitan Gastroenterology Associates
Metairie, Louisiana, 70006, 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
Boston VA Healthcare System
West Roxbury, Massachusetts, 02132, United States
Vida Clinical Studies
Dearborn, Michigan, 48124, United States
National Clinical, LLC
Hamtramck, Michigan, 48212, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519, United States
MNGI Digestive Health
Coon Rapids, Minnesota, 55446, United States
Synexus Clinical Research US, Inc.
Richfield, Minnesota, 55423, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Synexus Clinical Research
Henderson, Nevada, 89052, 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, 89135, United States
Garden State Endocrinology
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
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
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
PMG Research Salisbury
Salisbury, North Carolina, 28144, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Dayton Gastroenterology,Inc.
Beavercreek, Ohio, 45440, United States
Endocrinology Research Associates, Inc.
Columbus, Ohio, 43201, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, 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
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112, United States
Memorial Clinical Research
Oklahoma City, Oklahoma, 73120, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97210, United States
Family Medical Associates, Research Department
Levittown, Pennsylvania, 19056, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Montgomery Medical, Inc.
Smithfield, Pennsylvania, 15478, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621, 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
Quality Medical Research
Nashville, Tennessee, 37211, United States
Avant Research Associates,LLC
Austin, Texas, 78704, United States
Synexus Clinical Research US, Inc.
Dallas, Texas, 75234, United States
Amir Ali Hassan, MD, PA
Houston, Texas, 77089, 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.
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
Cardinal Internal Medicine
Woodbridge, Virginia, 22192, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
MHAT Yuliya Vrevska Byala
Byala, Ruse, 7100, Bulgaria
UMHAT - Kaspela- EOOD
Plovdiv, 4001, Bulgaria
Medical Center Asklepion - Humane Medicine Research EOOD
Sofia, 1303, Bulgaria
Alexandrovska University Hospital
Sofia, 1431, Bulgaria
CHU Nantes
Nantes, 44093, France
Hopital Charles Nicolle
Rouen, 76031, France
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
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 Pvt. Ltd
Pune, Maharashtra, 411013, India
S R Kalla (SRK) Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
SMS Hospital
Jaipur, Rajasthan, 302004, India
Diabetic Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006, India
Marudhar Hospital
Jaipur, Rajasthan, 302012, India
Eternal Hospital - Diabetology
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
M V Hospital & Research Centre
Lucknow, Uttar Pradesh, 226003, India
Arthur Asirvatham Hospital
Madurai, 625020, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Soroka University Medical Center
Beersheba, 85025, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
E. Wolfson Medical Center
Holon, 58100, Israel
Digestive Diseases Institute
Jerusalem, 9103102, Israel
Gastroenterology Institute
Petah Tikva, 49100, Israel
Endocrinology & Diabetes Center
Safed, 13100, Israel
Gastroenterology Institute
Tel Aviv, 64239, Israel
Hospital Sultanah Bahiyah
Alor Star, Kedah, 5460, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Universiti Sains Malaysia
Kubang Kerian, 16150, Malaysia
Hospital Taiping
Taiping, 34000, Malaysia
Manila Doctors Hospital
Ermita, Manila, 1000, Philippines
San Juan De Dios Educational Foundation, Inc.
Pasay, National Capital Region, 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
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
St. Luke's Medical Center
Quezon City, 1100, Philippines
Synexus Polska Sp.z o.o.
Pomorskie, Gdansk, 80-382, Poland
CenterMed Krakow Ltd
Krakow, Malopolska, 31-530, Poland
Centrum Medyczne Pratia S.A. Warsaw, Poland
Warsaw, Mazowian, 01-868, Poland
Endoskopia Sp. Z O.O.
Sopot, Pomeranian Voivodeship, 81-756, Poland
Synexus Polska Sp. z o.o.Oddzial w Poznaniu
Poznan, Poznañ, 60-702, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-561, Poland
NZOZ Vita Diabetica - Malgorzata Buraczyk
Bialystok, 15-798, Poland
Centrum Medyczne Lukamed
Chojnice, 89-600, Poland
Synexus Polska sp.z.o.o oddzial Czestochowa
Częstochowa, 42-202, Poland
Specjalistyczny Gabinet Neurologiczny Marta Banach
Krakow, 30-539, Poland
Synexus Polska Sp. z o.o. Oddzial w Lodzi
Lodz, 90-127, Poland
Sanitas Centrum Medyczne
Lublin, 20-090, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Poland
DRS Wroclaw
Wroclaw, 50-381, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw, 51-162, Poland
National University Hospital
Singapore, 119228, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Singapore General Hospital
Singapore, S169856, Singapore
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712, South Korea
Sanggye Paik Hospital, Inje University College of Medicine
Seoul, Nowon-gu, 01757, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Universitario Principe de Asturias
Madrid, 28850, Spain
Hospital Universitario De Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocío
Seville, 41009, 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
Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
Odesa, Odesa Oblast, 65025, Ukraine
Limited Liability Company "Medical Center "Salutem"
Vinnitsa, Vinnytsia Oblast, 21050, Ukraine
Municipal Institution City Hospital No. 7
Zaporizhzhia, Zaporizhzhia Oblast, 69600, Ukraine
Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C
Chernivtsi, 58001, Ukraine
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
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
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
Kyiv municipal clinical endocrinological center
Kyiv, 01034, Ukraine
AS Medbud Clinic
Kyiv, 03037, Ukraine
AS PVNZ
Kyiv, 2002, Ukraine
Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
Kyiv, 2002, Ukraine
Kyiv Railway hospital on the railway transport #2 of the branch "health
Kyiv, 3049, Ukraine
Medical Center Universal Clinic Oberig
Kyiv, 3680, 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
Ternopil University Hospital
Ternopil, 46002, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Wieslaw (Wes) Bochenek, MD, PhD
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2017
First Posted
September 18, 2017
Study Start
September 29, 2017
Primary Completion
July 8, 2020
Study Completion
July 8, 2020
Last Updated
July 29, 2021
Results First Posted
July 29, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share