Status:
TERMINATED
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
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 :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2020
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT03426345
Start Date
February 16 2018
End Date
July 16 2020
Last Update
August 6 2021
Active Locations (240)
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1
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
2
Synexus Clinical Research US - Simon Williamson Clinic
Birmingham, Alabama, United States, 35211
3
G & L Research, LLC
Foley, Alabama, United States, 36535
4
Alabama Medical Group, PC
Mobile, Alabama, United States, 36608