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

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 (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.

Condition Intervention Phase
Ulcerative Colitis in Remission
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 Ulcerative Colitis in Remission Phase

Resource links provided by NLM:

Further study details as provided by Tillotts Pharma AG:

Primary Outcome Measures:
  • Rate of non-emergence of bloody stool [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 251
Study Start Date: November 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asacol®
Import Mesalazine
Drug: Asacol®
400 mg 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 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.
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Please refer to this study by its identifier: NCT01257399

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

Responsible Party: Tillotts Pharma AG Identifier: NCT01257399     History of Changes
Other Study ID Numbers: 03010302A  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