At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 593 enrolled
Drug / intervention
Tenapanor +1 moredrug
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 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
In Brief
A Phase 3 clinical trial evaluating Tenapanor and Placebo for Constipation Predominant Irritable Bowel Syndrome. Completed, enrolled 593 participants across 117 sites.
Detailed Summary
This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose of Tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for a 26 week treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedFeb 2016
Primary CompletionAug 2017
Study CompletionOct 2017
TodayJul 2026
First PostedFeb 19, 2016
Enrollment StartDec 1, 2015
Primary CompletionAug 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.4 years ago
Interventions
Tenapanordrug
Placebodrug