NCT03977155

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 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Boston Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	BOS-589	oral tablets
DRUG	Placebo	oral tablets

Timeline

• Start date: 2019-06-04
• Primary completion: 2020-05-06
• Completion: 2020-05-06
• First posted: 2019-06-06
• Last updated: 2021-06-07
• Results posted: 2021-06-07

Locations

58 sites across 1 country: United States

Regulatory

• FDA-regulated drug study