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

Constipation Predominant Irritable Bowel Syndrome Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340053
• Other study ID #: RDX5791-201
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2019
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• RDX5791
Capsule, QD

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 4
Secondary	Spontaneous Bowel Movement (SBM) Frequency Change From Baseline		baseline and week 4

External Links

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