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NCT00189696 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189696
Other study ID # 060-CL-202
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated October 9, 2015

Study information
Verified date October 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 64 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• YM060

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Matsueda K, Harasawa S, Hongo M, Hiwatashi N, Sasaki D. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome. Scand J Gastroenterol. 2008;43(10):1202-11. doi: 10.1080/00365520802240255. — View Citation

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