Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily|
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|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|