A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

Phase 3 Completed 577 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Timeline

Start: 2013-02
Primary completion: 2014-02
Completion: 2014-02

Outcome

Met primary endpoint

paper A significantly higher proportion of patients given ramosetron reported global improvement (50.7%; 95% confidence interval [CI], 44.8-56.6) than patients given placebo (32.0%; 95% CI, 26.7-37.8) PMID 26551550 ↗

paper A significantly higher proportion of patients in the ramosetron group reported increased stool consistency (40.8%; 95% CI, 35.1%-46.6%) than in the placebo group PMID 26551550 ↗

Publications

Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramosetron	Small molecule	2.5 ug	Oral