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NCT02959983 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 346
- Enrollment target
NCT02959983: Completed Phase 4 study, sponsored by Allergan.
NCT02959983 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 346 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02959983, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 346 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms.
Primary Outcome
Percentage of primary composite responders is defined as the percentage of participants who meet both of the following daily composite criteria for at least 50% of the days with diary entry: 1)Worst Abdominal Pain (WAP) score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) Bristol Stool Score (BSS) \<5; or the absence of a bowel movement if accompanied by ≥40% im
Interventions
- DRUG Placebo
- DRUG Eluxadoline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2016-10-25 |
| Est. Completion | 2018-01-22 |
| Phase | Phase 4 |
What the finished NCT02959983 record still lists
NCT02959983 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02959983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02959983 about?
NCT02959983 is a clinical study titled "Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use". This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D...
What is the current status of trial NCT02959983?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 346 participants. The study started on 2016-10-25. Estimated completion is 2018-01-22.
What interventions are being tested in trial NCT02959983?
The interventions under investigation include: Placebo (DRUG), Eluxadoline (DRUG).
Who is sponsoring clinical trial NCT02959983?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02959983's enrollment target sits among peer trials
346 242nd of 2000 higher than 1,757 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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