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

Tracking Information
First Received Date ^ICMJE	December 8, 2010
Last Updated Date	April 3, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2010)	Reduction degree of UC-DAI [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01257386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 8, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Official Title ^ICMJE	Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Active Ulcerative Colitis
Intervention ^ICMJE	Drug: Asacol® 400mg tablets Other Name: Import Mesalazine Drug: Mesalazine 400mg tablets Other Name: Marketed Mesalazine
Study Arm (s)	Experimental: Asacol® Import Mesalazine Intervention: Drug: Asacol® Active Comparator: Mesalazine Marketed Mesalazine Intervention: Drug: Mesalazine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	251
Completion Date	March 2013
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01257386
Other Study ID Numbers ^ICMJE	03010301A, 2007L03525
Has Data Monitoring Committee	No
Responsible Party	Tillotts Pharma AG
Study Sponsor ^ICMJE	Tillotts Pharma AG
Collaborators ^ICMJE	Zeria Pharmaceutical
Investigators ^ICMJE	Not Provided
Information Provided By	Tillotts Pharma AG
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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