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

Completed · Phase 2 · Has a placebo group

Conditions studied: Constipation Predominant Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT01340053

Run by

Ardelyx

People needed

186

Starts

2011-05-01

Expected to finish

2012-02-01

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ardelyx Investigational Site — San Diego, California, United States
• Ardelyx Investigational Site — Jupiter, Florida, United States
• Ardelyx Investigational Site — Pinellas Park, Florida, United States
• Ardelyx Investigational Site — Rockford, Illinois, United States
• Ardelyx Investigational Site — Mission, Kansas, United States
• Ardelyx Investigational Site — Monroe, Louisiana, United States
• Ardelyx Investigational Site — Annapolis, Maryland, United States
• Ardelyx Investigational Site — Chesterfield, Michigan, United States
• Ardelyx Investigational Site — St Louis, Missouri, United States
• Ardelyx Investigational Site — Brooklyn, New York, United States
• Ardelyx Investigational Site — Greensboro, North Carolina, United States
• Ardelyx Investigational Site — Oklahoma City, Oklahoma, United States
• Ardelyx Investigational Site — Simpsonville, South Carolina, United States
• Ardelyx Investigational Site — Bristol, Tennessee, United States
• Ardelyx Investigational Site — Ogden, Utah, United States
• Ardelyx Investigational Site — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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