Status:
COMPLETED
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis
Eligibility Criteria
Inclusion
- Inclusion Criteria (main):
- Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
- Established or new diagnosis
- Disease activity at baseline: Clinical Activity Index (CAI) \>4 and Endoscopic Index (EI) \>= 4
- Exclusion Criteria (main):
- Crohn's disease
- Toxic megacolon
- Present or past colorectal cancer
- Symptomatic gastrointestinal disease
- Serious secondary disease(s)
- Baseline stool positive for germs causing bowel disease
- Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
- Current relapse occurred under maintenance treatment with \>2g/day mesalazine
- Serum creatinine \>= 1.2x upper limit of normal (ULN) and creatinine clearance \< 60 ml/min per 1.73 m2
- Serum transaminase (ALT and/or AST), and/or alkaline phosphatase \>= 2x ULN
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00449722
Start Date
July 1 2005
End Date
June 1 2006
Last Update
January 21 2016
Active Locations (1)
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1
Evangelisches Krankenhaus Kalk
Cologne, Germany, 51103