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NCT03977155 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study, sponsored by Boston Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
NCT03977155: Completed Phase 2 study, sponsored by Boston Pharmaceuticals.
NCT03977155 is a Phase 2 study that has completed, run by Boston Pharmaceuticals. The registered enrollment target is 133 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03977155, a Phase 2 study, has completed, sponsored by Boston Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment and to evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo (PBO).
Primary Outcome
To evaluate in participants with diarrhea-predominant irritable bowel syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment, relative to placebo. Throughout the 4 weeks of the double blind treatment phase, participants were asked to rate their WAP in the past 24 hours. The participant-reported WAP in the past 24 hours was recorded on a 0 to 10 scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. Higher scores indicated worse outcome.
Interventions
- DRUG Placebo
- DRUG BOS-589
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 2 |
What the finished NCT03977155 record still lists
NCT03977155 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03977155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03977155 about?
NCT03977155 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)". This study is being conducted to evaluate in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment and to evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment,...
What is the current status of trial NCT03977155?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2019-06-04. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT03977155?
The interventions under investigation include: Placebo (DRUG), BOS-589 (DRUG).
Who is sponsoring clinical trial NCT03977155?
This trial is sponsored by Boston Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03977155's enrollment target sits among peer trials
133 538th of 2000 higher than 1,462 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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