Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Active Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Asacol®

Import Mesalazine

Group Type EXPERIMENTAL

Asacol®

Intervention Type DRUG

400mg tablets

Mesalazine

Marketed Mesalazine

Group Type ACTIVE_COMPARATOR

Mesalazine

Intervention Type DRUG

400mg tablets

Interventions

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Asacol®

400mg tablets

Intervention Type DRUG

Mesalazine

400mg tablets

Intervention Type DRUG

Other Intervention Names

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Import Mesalazine Marketed Mesalazine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No