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

Ardelyx

Status and phase: Completed; Phase 2

Conditions: Constipation Predominant Irritable Bowel Syndrome

Treatments: Drug: RDX5791

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340053

RDX5791-201

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Capsule that is identical in size and color to other treatments

Treatment:

Drug: RDX5791

Low Dose

Experimental group

Description:

10 mg capsule of tenapanor

Treatment:

Drug: RDX5791

Mid Dose

Experimental group

Description:

30 mg capsule of tenapanor

Treatment:

Drug: RDX5791

High Dose

Experimental group

Description:

100 mg capsule of tenapanor

Treatment:

Drug: RDX5791