Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Astellas

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Drug: YM060

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189696

060-CL-202

Details and patient eligibility

About

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

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients satisfying the Rome II Diagnostic Criteria.
• Patients in whom no organic changes were observed in large intestine.

Exclusion criteria

• Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
• Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind