Skip to main content
OpenTrials
Completed

NCT Number: NCT01340053

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Predominant Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ardelyx Investigational Site, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RDX5791

Drug

Capsule, QD

Primary outcomes

  1. Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline

    Time frame: 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 outcomes

  1. Spontaneous Bowel Movement (SBM) Frequency Change From Baseline

    Time frame: baseline and week 4

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of RDX5791 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 22, 2011
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.