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Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01257386
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : April 4, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Active Ulcerative Colitis Drug: Asacol® Drug: Mesalazine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Study Start Date : November 2010
Primary Completion Date : August 2012
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Asacol®
Import Mesalazine
Drug: Asacol®
400mg tablets
Other Name: Import Mesalazine
Active Comparator: Mesalazine
Marketed Mesalazine
Drug: Mesalazine
400mg tablets
Other Name: Marketed Mesalazine


Outcome Measures

Primary Outcome Measures :
  1. Reduction degree of UC-DAI [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate [ Time Frame: Week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257386


Locations
China
Shanghai Hospital
Shanghai, China
Sponsors and Collaborators
Tillotts Pharma AG
Zeria Pharmaceutical
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tillotts Pharma AG
ClinicalTrials.gov Identifier: NCT01257386     History of Changes
Other Study ID Numbers: 03010301A
2007L03525 ( Other Grant/Funding Number: SFDA_CTA )
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents