Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
- Registration Number
- NCT01781104
- Lead Sponsor
- Motus Therapeutics, Inc.
- Brief Summary
The purpose of this study is to evaluate safety and tolerability as well as the effects of RM-131 on colonic transit, bowel consistency, bowel habits, abdominal pain, and other abdominal symptoms in patients with chronic constipation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - RM-131 RM-131 -
- Primary Outcome Measures
Name Time Method Effect of RM-131 on colonic transit End of 14 day Baseline and end of 14 day Treatment periods Change from baseline colonic geometric center at 24 hours
- Secondary Outcome Measures
Name Time Method Safety and tolerability of RM-131 Duration of the study, an expected average of 9 weeks Assessment of adverse events and clinical laboratory evaluations
Effect of RM-131 on stool consistency Daily for the duration of the study, an expected average of 9 weeks Change in responses on Bowel Habit Diary Cards
Trial Locations
- Locations (3)
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States