drugset / Trial / NCT01923428

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

NCT01923428

Phase 2/3 Completed 356 enrolled Ardelyx
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-08
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 5 mg
Subject Tenapanor Small molecule 20 mg
Subject Tenapanor Small molecule 50 mg