drugset / Trial / NCT01340053
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2011-05
- Primary completion
- 2011-12
- Completion
- 2012-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenapanor | Small molecule | 10 mg | — |
| Subject | Tenapanor | Small molecule | 30 mg | — |
| Subject | Tenapanor | Small molecule | 100 mg | — |