Phase 3
Completed N=312
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Constipation Predominant Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT02727751 ↗
Enrolled (actual)
312
Serious AEs
1.0%
Results posted
Apr 2020
Primary outcomePrimary: Adverse Events in >2% Patients — 33; 7; 7; 11 participants
◆ Published Evidence
Established
68citations · ~14 / year
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).
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.
Linked Publications (2)
-
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).
-
Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events in >2% Patients |
33; 7; 7; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
- Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
- Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
- Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
Exclusion Criteria
- Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
- The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02727751) and the linked publication. 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. Informational only — not medical advice.