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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx

Criteria

Inclusion Criteria:

• Subject meets Rome III criteria for IBS-C

• If > 50 years old, colonoscopy evaluation within 10 years

• All ages, negative colonoscopy if any "warning symptoms"

• Active disease during 2-week screening period

• Compliant with IVRS

Exclusion Criteria:

• Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria

• Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract

• Use of medications that are known to affect stool consistency

• Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study