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NCT02621892 · ClinicalTrials.gov registry record · Phase 3
A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C
A Phase 3 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 3
- Development phase
- 606
- Enrollment target
NCT02621892 is a Phase 3 study that has completed, run by Ardelyx. The registered enrollment target is 606 participants.
The verdict
NCT02621892, a Phase 3 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 606 participants
- Enrollment target
Study Summary
This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12 week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.
Interventions
- DRUG Placebo
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02621892
The ClinicalTrials.gov registry entry for NCT02621892 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 606 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 2 interventions - of which Placebo is the first listed.
NCT02621892 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02621892 about?
NCT02621892 is a clinical study titled "A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C". This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a ...
What is the current status of trial NCT02621892?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2015-10. Estimated completion is 2017-04.
What interventions are being tested in trial NCT02621892?
The interventions under investigation include: Placebo (DRUG), Tenapanor (DRUG).
Who is sponsoring clinical trial NCT02621892?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
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