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NCT01340053 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
A Phase 2 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 2
- Development phase
- 186
- Enrollment target
NCT01340053: Completed Phase 2 study, sponsored by Ardelyx.
NCT01340053 is a Phase 2 study that has completed, run by Ardelyx. The registered enrollment target is 186 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01340053, a Phase 2 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 186 participants
- Enrollment target
Study 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.
Primary Outcome
Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.
Interventions
- DRUG RDX5791
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01340053 record still lists
NCT01340053 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 1 intervention - of which RDX5791 is the first listed.
NCT01340053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01340053 about?
NCT01340053 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)". 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 d...
What is the current status of trial NCT01340053?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2011-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01340053?
The interventions under investigation include: RDX5791 (DRUG).
Who is sponsoring clinical trial NCT01340053?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01340053's enrollment target sits among peer trials
186 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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