Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily
(QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses
(BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks,
in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI)
score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema
containing 1g of mesalazine at bedtime during the initial 4 weeks.
Participants in remission at week 8 received an additional 4 weeks of maintenance therapy
with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8
completed the study at week 8.