A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis
- Conditions
- lcerative colitisMedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
- Registration Number
- EUCTR2004-005032-35-IT
- Lead Sponsor
- ALIZYME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 890
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method