CompletedPhase 2

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

United States186 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT01340053

SponsorArdelyx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

Results submitted2019-08-15

View on ClinicalTrials.gov More Constipation Predominant Irritable Bowel Syndrome trials