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

Phase 2

Completed

• Conditions: Constipation Predominant Irritable Bowel Syndrome
• Interventions: Drug: RDX5791

• Registration Number: NCT01340053
• Lead Sponsor: Ardelyx

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-22
• Study Start: 2011-05
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Results First Submitted: 2019-08-15
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-10-15
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	RDX5791	10 mg capsule of tenapanor
Mid Dose	RDX5791	30 mg capsule of tenapanor
Placebo	RDX5791	Capsule that is identical in size and color to other treatments
High Dose	RDX5791	100 mg capsule of tenapanor

Primary Outcome Measures

Name	Time	Method
Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline	Baseline and Week 4	Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.

Secondary Outcome Measures

Name	Time	Method
Spontaneous Bowel Movement (SBM) Frequency Change From Baseline	baseline and week 4

Trial Locations

Locations (1)

Ardelyx Investigational Site; 🇺🇸 Lynchburg, Virginia, United States