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

April 3, 2013 updated by: Tillotts Pharma AG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Asacol®
Import Mesalazine
Drug: Asacol®
400 mg tablets
Other Names:
  • Import Mesalazine
ACTIVE_COMPARATOR: Mesalazine
Marketed Mesalazine
Drug: Mesalazine
400mg tablets
Other Names:
  • Marketed Mesalazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of non-emergence of bloody stool
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tillotts Pharma AG

Collaborators

Zeria Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (ESTIMATE)

December 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03010302A
  • 2007L03525 (OTHER_GRANT: SFDA_CTA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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