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

This study has been completed.
Sponsor:
Collaborator:
Zeria Pharmaceutical
Information provided by (Responsible Party):
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT01257399
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 (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:

U.S. FDA Resources

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

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257399

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: 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
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 May 21, 2013