OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis

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

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