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

Ardelyx186 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

186

Conditions

Constipation Predominant Irritable Bowel Syndrome

Interventions

RDX5791DRUG

Capsule, QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (16)

Ardelyx Investigational Site

San Diego, California, United States

Ardelyx Investigational Site

Jupiter, Florida, United States

Outcomes

Primary Outcomes

Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline

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.

Time frame: Baseline and Week 4

Secondary Outcomes

Spontaneous Bowel Movement (SBM) Frequency Change From Baseline

Time frame: baseline and week 4

Data from ClinicalTrials.gov

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