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Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborator:
Zeria Pharmaceutical
Information provided by (Responsible Party):
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT01257386
First received: December 8, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257386

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

No publications provided

Responsible Party: Tillotts Pharma AG
ClinicalTrials.gov 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
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013