A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C — T3MPO-2  

Constipation Predominant Irritable Bowel Syndrome Clinical Trial

Official title: 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)

Status Completed

Clinical Trial 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.

Clinical Trial Description

During the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. Subjects will also record weekly assessments including: adequate relief of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity. ;

Related Conditions & MeSH terms

• Constipation
• Constipation Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

• NCT number: NCT02686138
• Study type: Interventional
• Source: Ardelyx
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Completion date: October 2017