Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

This study has been completed.
Zeria Pharmaceutical
Information provided by (Responsible Party):
Tillotts Pharma AG Identifier:
First received: December 8, 2010
Last updated: April 3, 2013
Last verified: April 2013
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 Intervention Phase
Active Ulcerative Colitis
Drug: Asacol®
Drug: Mesalazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by Tillotts Pharma AG:

Primary Outcome Measures:
  • Reduction degree of UC-DAI [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]

Enrollment: 251
Study Start Date: November 2010
Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01257386

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

Responsible Party: Tillotts Pharma AG Identifier: NCT01257386     History of Changes
Other Study ID Numbers: 03010301A  2007L03525 
Study First Received: December 8, 2010
Last Updated: April 3, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Colitis, Ulcerative
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016