Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC
- Conditions
- Maintenance therapy of ulcerative colitis
- Registration Number
- EUCTR2004-001218-15-SI
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
- Signed informed consent
- Men or women aged 18 to 75 years
- Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology
- Patient being in remission, defined as: Clinical Activity Index (CAI) <= 4 and Endoscopic Index (EI) < 4
- Extent of inflammation during last acute episode was >= 15 cm beyond the anal margin
- Last acute episode ended within 3 months prior to study entry
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
- Crohn’s disease
- Prior bowel resection leading to diarrhoea
- Toxic megacolon
- Gastric or duodenal ulcer
- Haemorrhagic diathesis
- Present or past colorectal cancer
- Symptomatic gastrointestinal disease
- Serious secondary disease(s)
- Asthma
- Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
- Serum creatinine > 1.5 mg/dl and/or serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x upper limit of normal
- Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method