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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: Completed Phase 3 study, sponsored by Ardelyx.
NCT02621892 is a Phase 3 study that has completed, run by Ardelyx. The registered enrollment target is 606 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An overall responder is defined as a weekly responder for the first 6/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain respon
Interventions
- DRUG Placebo
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-04 |
| Phase | Phase 3 |
What the finished NCT02621892 record still lists
NCT02621892 is an interventional study that assigns participants to a tested intervention. The registered 606 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02621892 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02621892's enrollment target sits among peer trials
606 606th of 2000 higher than 1,394 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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