A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of RM-131 Administered to Patients With Chronic Constipation

Motus Therapeutics, Inc.3 sites in 1 country48 target enrollmentMarch 2013

ConditionsConstipation

InterventionsRM-131 Placebo

DrugsRM-131 Placebo

Overview

Phase: Phase 2
Intervention: RM-131
Conditions: Constipation
Sponsor: Motus Therapeutics, Inc.
Enrollment: 48
Locations: 3
Primary Endpoint: Effect of RM-131 on colonic transit
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

October 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Motus Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

RM-131

Intervention: RM-131

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Effect of RM-131 on colonic transit

Time Frame: End of 14 day Baseline and end of 14 day Treatment periods

Change from baseline colonic geometric center at 24 hours

Secondary Outcomes

Safety and tolerability of RM-131(Duration of the study, an expected average of 9 weeks)
Effect of RM-131 on stool consistency(Daily for the duration of the study, an expected average of 9 weeks)