NCT02686138

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 593 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Constipation Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Tenapanor
DRUG	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-08-01
• Completion: 2017-10-01
• First posted: 2016-02-19
• Last updated: 2020-04-22
• Results posted: 2020-04-13

Locations

117 sites across 1 country: United States