A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Astellas

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: YM060

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189813

060-CL-305

Details and patient eligibility

About

This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Enrollment: 691 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

Exclusion criteria

• Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
• Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind