NCT00209300

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Pentasa

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-05-01
• Completion: 2007-06-01
• First posted: 2005-09-21
• Last updated: 2011-05-19

Locations

69 sites across 8 countries: Belgium, Czechia, Denmark, Finland, Germany, Netherlands, Norway, Sweden