A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis
Phase 3
- Conditions
- Health Condition 1: E106- Type 1 diabetes mellitus with other specified complicationsHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2019/03/018110
- Lead Sponsor
- Allergan LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
1.Diagnosis of Type 1 or Type 2 diabetes mellitus
2.Meet the per protocol criteria of diabetic gastroparesis
3.Compliance with diary
4.Compliance with the per protocol study treatment dosing instructions
Exclusion Criteria
1.Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
2.History of an eating disorder (e.g., anorexia nervosa, binge-eating, bulimia) in the past 5 years
3.Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
4.History of gastrointestinal disorders that may be similar to gastroparesis
5.Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.% of patients meeting the diabetic gastroparesis(DG) symptom responder criterion in each of the last 6 of the 12 weeks of treatment . Patients will assess severity of DG symptoms daily using an 11 point ordinal scale with 0 (least) and 10 (worst) possible score. Patients will enter the score using an e diary. <br/ ><br>2.% of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment. Vomiting episodes will be patient-recorded daily using an e diary <br/ ><br>Timepoint: 1) Baseline, 12 Weeks <br/ ><br>2) 12 weeks
- Secondary Outcome Measures
Name Time Method