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NCT01923428 · ClinicalTrials.gov registry record · Phase 2
The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)
A Phase 2 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 2
- Development phase
- 356
- Enrollment target
NCT01923428: Completed Phase 2 study, sponsored by Ardelyx.
NCT01923428 is a Phase 2 study that has completed, run by Ardelyx. The registered enrollment target is 356 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01923428, a Phase 2 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 356 participants
- Enrollment target
Study Summary
This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.
Primary Outcome
Weekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks
Interventions
- DRUG Placebo
- DRUG AZD1722
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01923428 record still lists
NCT01923428 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (168% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01923428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01923428 about?
NCT01923428 is a clinical study titled "The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)". This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week s...
What is the current status of trial NCT01923428?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 356 participants. The study started on 2013-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01923428?
The interventions under investigation include: Placebo (DRUG), AZD1722 (DRUG).
Who is sponsoring clinical trial NCT01923428?
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 NCT01923428's enrollment target sits among peer trials
356 128th of 2000 higher than 1,873 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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