Status:
TERMINATED
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Lead Sponsor:
Allergan
Conditions:
Gastroparesis
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 gastro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT03285308
Start Date
September 29 2017
End Date
July 8 2020
Last Update
July 29 2021
Active Locations (216)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35295
2
Digestive Health Specialist of the South East
Dothan, Alabama, United States, 36305
3
Avant Research Associates
Huntsville, Alabama, United States, 35801
4
Synexus Clinical Research US, Inc.
Fountain Hills, Arizona, United States, 85268