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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 is a Phase 2 study that has completed, run by Ardelyx. The registered enrollment target is 356 participants.
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.
Interventions
- DRUG Placebo
- DRUG AZD1722
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01923428
The ClinicalTrials.gov registry entry for NCT01923428 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 356 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.
NCT01923428 reports 0 study locations.
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.
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