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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Mesalamine

Criteria

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