drugset / Trial / NCT01340053

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

NCT01340053

Phase 2 Completed 186 enrolled Ardelyx
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-05
Primary completion
2011-12
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 10 mg
Subject Tenapanor Small molecule 30 mg
Subject Tenapanor Small molecule 100 mg