Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug,
marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool),
in patients with Ulcerative Colitis in remission, treated for 48 weeks.