A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Phase 2
Completed
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT00189813
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 691
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie YM060's 5-HT3 receptor antagonism in treating diarrhea-predominant IBS?
How does YM060's efficacy in d-IBS compare to standard-of-care agents like loperamide or eluxadoline?
Are there specific biomarkers (e.g., gut microbiota, inflammatory markers) predictive of YM060 response in d-IBS patients?
What adverse events were reported in NCT00189813 and how do they align with 5-HT3 antagonist safety profiles?
What post-2005 advancements in 5-HT3 receptor modulators for IBS have emerged since Astellas Pharma's YM060 trial?