At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 312 enrolled
Drug / intervention
Tenapanordrug
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.
An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
In Brief
A Phase 3 clinical trial evaluating Tenapanor for Constipation Predominant Irritable Bowel Syndrome. Completed, enrolled 312 participants across 1 site.
Detailed Summary
This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedApr 2016
Primary CompletionOct 2017
TodayJul 2026
First PostedApr 5, 2016
Enrollment StartMar 1, 2016
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago
Interventions
Tenapanordrug