Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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.