Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Tillotts Pharma

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis in Remission

Treatments: Drug: Asacol®; Drug: Mesalazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257399

03010302A

2007L03525 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ulcerative colitis in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.

Exclusion criteria

• Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.

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