Status:
COMPLETED
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Europe B.V.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
691 Patients enrolled
Trial Details
Trial ID
NCT00189813
Start Date
March 1 2005
End Date
December 1 2005
Last Update
August 28 2014
Active Locations (45)
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1
Plovdiv, Bulgaria
2
Sofia, Bulgaria
3
Varna, Bulgaria
4
České Budějovice, Czechia