Trial | NCT00449722  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mesalamine ...

  • Study Participants

    380
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
Study Started
Jul 31
2005
Study Completion
Jun 30
2006
Last Update
Jan 21
2016
Estimate

Drug mesalazine

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
No Results Posted