Conditions: Constipation Predominant Irritable Bowel Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 186
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Capsule that is identical in size and color to other treatments arm 2: 10 mg capsule of tenapanor arm 3: 30 mg capsule of tenapanor arm 4: 100 mg capsule of tenapanor

Interventions: intervention 1: RDX5791
Intervention descriptions: intervention 1: Capsule, QD

Protocol document: