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NCT04043455 · ClinicalTrials.gov registry record · Phase 2
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
A Phase 2 study, sponsored by Arena Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 273
- Enrollment target
NCT04043455: Clinical Trial Phase 2 study, sponsored by Arena Pharmaceuticals.
NCT04043455 is a Phase 2 study that was terminated before completion, run by Arena Pharmaceuticals. The registered enrollment target is 273 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04043455, a Phase 2 study, was terminated before completion, sponsored by Arena Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 273 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).
Primary Outcome
The APS is a single question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. The change in AAPS from Baseline at Week 12 was analyzed using a mixed-effects model repeated measures (MMRM) analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. An unstructured variance-covariance matrix was used for the MMRM analysis.
Interventions
- DRUG Placebo
- DRUG Olorinab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2019-07-24 |
| Est. Completion | 2021-04-29 |
| Phase | Phase 2 |
Why NCT04043455 stopped before completion
NCT04043455 is an interventional study that assigns participants to a tested intervention. The registered 273 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 (105% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04043455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04043455 about?
NCT04043455 is a clinical study titled "Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)". The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).
What is the current status of trial NCT04043455?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 273 participants. The study started on 2019-07-24. Estimated completion is 2021-04-29.
What interventions are being tested in trial NCT04043455?
The interventions under investigation include: Placebo (DRUG), Olorinab (DRUG).
Who is sponsoring clinical trial NCT04043455?
This trial is sponsored by Arena Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04043455's enrollment target sits among peer trials
273 204th of 2000 higher than 1,797 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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