A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

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.

Timeline

Start

2015-12

Primary completion

2017-08

Completion

2017-10

Publications

• Lacy BE, Shin AS, Cangemi DJ, Yang Y, Zhao S, Rosenbaum DP. Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis. Ther Adv Gastroenterol. 2026 Jan 24;19:17562848251414831. doi: 10.1177/17562848251414831. eCollection 2026.
• Lembo AJ, Friedenberg KA, Fogel RP, Edelstein S, Zhao S, Yang Y, Rosenbaum DP, Chey WD. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023 Nov;35(11):e14658. doi: 10.1111/nmo.14658. Epub 2023 Sep 5.
• Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.

Drugs

Indications