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OpenTrials
Completed

NCT Number: NCT01257399

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

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.

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Key information

Conditions

Ulcerative Colitis in Remission

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 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.

Treatment and study plan

Asacol®

Drug

400 mg tablets

Other names: Import Mesalazine

Mesalazine

Drug

400mg tablets

Other names: Marketed Mesalazine

Primary outcomes

  1. Rate of non-emergence of bloody stool

    Time frame: Week 48

Secondary outcomes

  1. 1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

Tillotts Pharma AG

Industry

Collaborators

  • Zeria Pharmaceutical

Registry information

Important dates

Study start
2010
Primary completion
2013
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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