Phase 2
N=186
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
Bottom Line
View on ClinicalTrials.gov: NCT01340053 ↗Enrolled (actual)
186
Serious AEs
1.1%
Results posted
Oct 2019
Primary outcome: Primary: Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline — 1.01; 1.50; 1.54; 1.57 number of bowel movements/week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RDX5791 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardelyx
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline |
1.01; 1.50; 1.54; 1.57 | — |
| SECONDARY Spontaneous Bowel Movement (SBM) Frequency Change From Baseline |
1.58; 2.37; 2.97; 2.81 | — |
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
Data sourced from ClinicalTrials.gov (NCT01340053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.