Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation

NCT01781104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-09-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RM-131

Double blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days.

DRUG

Placebo

Placebo delivered subcutaneously once daily for 14 days.

Sponsors & Collaborators

  • Motus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Elizabeth Stoner, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781104 on ClinicalTrials.gov