CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 356 enrolled
Drug / intervention
AZD1722 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01923428
NCT01923428Phase 3Completed

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)

Ardelyx·interventional·Posted Aug 15, 2013·Updated Apr 8, 2020

In Brief

A Phase 3 clinical trial evaluating AZD1722 and Placebo for Constipation Predominant Irritable Bowel Syndrome. Completed, enrolled 356 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 15, 2013
Enrollment StartAug 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.9 years ago

Interventions

AZD1722drug

Placebodrug