A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Summary

The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).

Timeline

Start

2013-04

Primary completion

2014-07

Completion

—

Outcome

Missed primary endpoint

paper Improvements in irritable bowel syndrome symptoms were seen with ONO-2952 over placebo in per-protocol analyses for all three co-primary endpoints, but these did not reach statistical significance at the 5% level. PMID 27910150 ↗

Publications

• Whitehead WE, Duffy K, Sharpe J, Nabata T, Bruce M. Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Jan;45(1):14-26. doi: 10.1111/apt.13839. Epub 2016 Nov 7.

Drugs

Indications