Conditions: Active Ulcerative Colitis Remission of Ulcerative Colitis
Keywords: Ulcerative Colitis 5-Aminosalicylate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 288
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.

Detailed description:
A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.

Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.

Arms:
arm 1: 5-ASA (5-Aminosalicylate) arm 2: 5-ASA (5-Aminosalicylate)

Interventions: intervention 1: 5-ASA (5-Aminosalicylate) intervention 2: 5-ASA (5-Aminosalicylate)
Intervention descriptions: intervention 1: 500 mg tablet (modified extended release) intervention 2: 500 mg tablet

Protocol document: