At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 186 enrolled
Drug / intervention
RDX5791drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating RDX5791 for Constipation Predominant Irritable Bowel Syndrome. Completed, enrolled 186 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionDec 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedApr 22, 2011
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.2 years ago
Interventions
RDX5791drug
Capsule, QD