Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Tillotts Pharma

Status and phase: Completed; Phase 3

Conditions: Active Ulcerative Colitis

Treatments: Drug: Asacol®; Drug: Mesalazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257386

2007L03525 (Other Grant/Funding Number)

03010301A

Details and patient eligibility

About

To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative colitis (UC) treated for 8 weeks.

Enrollment: 251 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Ulcerative Colitis (UC) at active phase who are defined to show Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher

Exclusion criteria

• Patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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251 participants in 2 patient groups

Asacol®

Experimental group

Description:

Import Mesalazine

Treatment:

Drug: Asacol®

Mesalazine

Active Comparator group

Description:

Marketed Mesalazine

Treatment:

Drug: Mesalazine