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

NCT ID: NCT01340053

Last Updated: 2019-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation Predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Capsule that is identical in size and color to other treatments

Group Type PLACEBO_COMPARATOR

RDX5791

Intervention Type DRUG

Capsule, QD

Low Dose

10 mg capsule of tenapanor

Group Type EXPERIMENTAL

RDX5791

Intervention Type DRUG

Capsule, QD

Mid Dose

30 mg capsule of tenapanor

Group Type EXPERIMENTAL

RDX5791

Intervention Type DRUG

Capsule, QD

High Dose

100 mg capsule of tenapanor

Group Type EXPERIMENTAL

RDX5791

Intervention Type DRUG

Capsule, QD

Interventions

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RDX5791

Capsule, QD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject meets Rome III criteria for IBS-C
* If \> 50 years old, colonoscopy evaluation within 10 years
* All ages, negative colonoscopy if any "warning symptoms"
* Active disease during 2-week screening period
* Compliant with IVRS

Exclusion Criteria

* Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria
* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
* Use of medications that are known to affect stool consistency
* Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ardelyx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David P Rosenbaum, Ph.D.

Role: STUDY_CHAIR

Ardelyx

Locations

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Ardelyx Investigational Site

San Diego, California, United States

Site Status

Ardelyx Investigational Site

Jupiter, Florida, United States

Site Status

Ardelyx Investigational Site

Pinellas Park, Florida, United States

Site Status

Ardelyx Investigational Site

Rockford, Illinois, United States

Site Status

Ardelyx Investigational Site

Mission, Kansas, United States

Site Status

Ardelyx Investigational Site

Monroe, Louisiana, United States

Site Status

Ardelyx Investigational Site

Annapolis, Maryland, United States

Site Status

Ardelyx Investigational Site

Chesterfield, Michigan, United States

Site Status

Ardelyx Investigational Site

St Louis, Missouri, United States

Site Status

Ardelyx Investigational Site

Brooklyn, New York, United States

Site Status

Ardelyx Investigational Site

Greensboro, North Carolina, United States

Site Status

Ardelyx Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Ardelyx Investigational Site

Simpsonville, South Carolina, United States

Site Status

Ardelyx Investigational Site

Bristol, Tennessee, United States

Site Status

Ardelyx Investigational Site

Ogden, Utah, United States

Site Status

Ardelyx Investigational Site

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Related Links

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http://www.ardelyx.com

Related Info

Other Identifiers

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RDX5791-201

Identifier Type: -

Identifier Source: org_study_id

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