At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 393 enrolled
Drug / intervention
Relamorelin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
In Brief
A Phase 2 clinical trial evaluating Relamorelin and Placebo for Diabetes Mellitus and 2 related conditions. Completed, enrolled 393 participants across 98 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Israel, Poland, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedFeb 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedFeb 6, 2015
Enrollment StartJan 29, 2015
Primary CompletionJun 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.4 years ago
Interventions
Relamorelindrug
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Placebodrug
Placebo given subcutaneously for 12 weeks.