A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Summary

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Timeline

Start

2009-06

Primary completion

2009-12

Completion

2009-12

Publications

• Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017.
• Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 11;11:7. doi: 10.1186/s13030-017-0092-x. eCollection 2017.

Drugs

Indications