MedTrace Logo

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

NCT01923428 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2020-04-08

Study results available
· View outcomes & findings →

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

DRUG

AZD1722

DRUG

Placebo

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • David P Rosenbaum, Ph.D. · Ardelyx, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923428 on ClinicalTrials.gov