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OpenTrials
Completed

NCT Number: NCT01257386

Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

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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Key information

Conditions

Active Ulcerative Colitis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asacol®

Drug

400mg tablets

Other names: Import Mesalazine

Mesalazine

Drug

400mg tablets

Other names: Marketed Mesalazine

Primary outcomes

  1. Reduction degree of UC-DAI

    Time frame: Week 8

Secondary outcomes

  1. 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Tillotts Pharma AG

Industry

Collaborators

  • Zeria Pharmaceutical

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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