Clinical trial NCT01340053: A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation Predominant Irritable Bowel Syndrome
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
timeFrame: baseline and week 4
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Ardelyx Investigational Site
state: California
city: Jupiter
country: United States
facility: Ardelyx Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Ardelyx Investigational Site
state: Florida
city: Rockford
country: United States
facility: Ardelyx Investigational Site
state: Illinois
city: Mission
country: United States
facility: Ardelyx Investigational Site
state: Kansas
city: Monroe
country: United States
facility: Ardelyx Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Ardelyx Investigational Site
state: Maryland
city: Chesterfield
country: United States
facility: Ardelyx Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: Ardelyx Investigational Site
state: Missouri
city: Brooklyn
country: United States
facility: Ardelyx Investigational Site
state: New York
city: Greensboro
country: United States
facility: Ardelyx Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Ardelyx Investigational Site
state: Oklahoma
city: Simpsonville
country: United States
facility: Ardelyx Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Ardelyx Investigational Site
state: Tennessee
city: Ogden
country: United States
facility: Ardelyx Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: Ardelyx Investigational Site
state: Virginia
Study officials:
affiliation: Ardelyx
name: David P Rosenbaum, Ph.D.
role: STUDY_CHAIR
References: