NCT01923428

The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of AZD1722 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.

Conditions

• Constipation Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	AZD1722
DRUG	Placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-08-15
• Last updated: 2020-04-08
• Results posted: 2020-01-10

Locations

4 sites across 1 country: United States