Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

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).

Timeline

Start

2019-06-04

Primary completion

2020-05-06

Completion

2020-05-06

Outcome

Missed primary endpoint

registry analysis (superiority test); BOS-589: Active Treatment vs Placebo; p = 0.3776; Mean Difference (Net) -0.31 (95% CI -1.00 to 0.38); t test NCT03977155 ↗

Drugs

Indications