Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Summary

This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months. Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months). Number of Subjects (Planned and Analysed): * 360 patients for demonstration of non-inferiority between once daily and twice daily; * 326 to be analysed in per-protocol (PP) analyses; and * 360 in intention-to-treat (ITT) analyses.

Timeline

Start

2005-05

Primary completion

2007-05

Completion

2007-06

Drugs

Indications