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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 is a Phase 2 study that has completed, run by Ardelyx. The registered enrollment target is 186 participants.
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.
Interventions
- DRUG RDX5791
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01340053
The ClinicalTrials.gov registry entry for NCT01340053 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ardelyx, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RDX5791 is the first listed.
NCT01340053 reports 0 study locations.
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.
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