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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
500 mg tablet (modified extended release)
500 mg tablet
University of Calgary, Faculty of Medicine
Calgary, Alberta, Canada
Active Phase: Proportion of Active Subjects Achieving Overall Improvement
Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI). Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1. A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score.
Time frame: From baseline to week 8
Maintenance Phase: Proportion of Subjects Experiencing Relapse
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy
Time frame: Up to week 24
Frequency of Adverse Events
Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.
Time frame: From baseline to week 24
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