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NCT00189813 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189813
Other study ID # 060-CL-305
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated August 27, 2014
Start date March 2005
Est. completion date December 2005

Study information
Verified date August 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlBulgaria: Bulgarian Drug AgencyEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 691
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

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 (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Estonia,  Germany,  Lithuania,  Poland,  Russian Federation,  Ukraine, 

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