A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

• Status: Terminated
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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