MedTrace Logo

A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)

NCT01340053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2019-10-15

Study results available
· View outcomes & findings →

Summary

This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial.

The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.

Conditions

  • Constipation Predominant Irritable Bowel Syndrome

Interventions

DRUG

RDX5791

Capsule, QD

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • David P Rosenbaum, Ph.D. · Ardelyx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT01340053 on ClinicalTrials.gov