Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Recruiting in Palo Alto (17 mi)
+57 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Boston Pharmaceuticals
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
Eligibility Criteria
Inclusion Criteria
Participant meets the diagnosis of diarrhea-predominant IBS (IBS-D) subtype based on Rome IV diagnostic criteria within 3 months prior to randomization. On days when the participant experiences IBS symptoms
At least 25% of stools are loose or watery;
Fewer than 25% of stools are hard.
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Treatment Details
Interventions
- BOS-589 (Other)
- Placebo (Drug)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low dose of BOS-589Experimental Treatment1 Intervention
Participants will receive a low dose of BOS-589 orally BID.
Group II: High dose of BOS-589Experimental Treatment1 Intervention
Participants will receive a high dose of BOS-589 orally twice a day (BID).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo orally BID.
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Who Is Running the Clinical Trial?
Boston Pharmaceuticals
Lead Sponsor
Trials
12
Recruited
910+