NCT01340053

A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of RDX5791 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial. The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.

Conditions

• Constipation Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	RDX5791	Capsule, QD

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2011-04-22
• Last updated: 2019-10-15
• Results posted: 2019-10-15

Locations

16 sites across 1 country: United States