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

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. Identifier: NCT01257399
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : April 4, 2013
Zeria Pharmaceutical
Information provided by (Responsible Party):
Tillotts Pharma AG

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis in Remission Drug: Asacol® Drug: Mesalazine Phase 3

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 Ulcerative Colitis in Remission Phase
Study Start Date : November 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of non-emergence of bloody stool [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT01257399

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tillotts Pharma AG Identifier: NCT01257399     History of Changes
Other Study ID Numbers: 03010302A
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, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents