At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 288 enrolled
Drug / intervention
5-ASA (5-Aminosalicylate) +1 moredrug
Likely dose
5-ASA (5-Aminosalicylate) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomised, 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
In Brief
A Phase 3 clinical trial evaluating 5-ASA (5-Aminosalicylate) for Active Ulcerative Colitis and Remission of Ulcerative Colitis. Completed, enrolled 288 participants across 27 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedJan 2008
Primary CompletionMay 2011
TodayJul 2026
First PostedJan 29, 2008
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.4 years ago
Interventions
5-ASA (5-Aminosalicylate)drug
500 mg tablet (modified extended release)
5-ASA (5-Aminosalicylate)drug
500 mg tablet