Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Active Ulcerative Colitis Clinical Trial

Official title:

Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257386
• Other study ID #: 03010301A
• Secondary ID: 2007L03525
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2010
• Last updated: April 3, 2013
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Tillotts Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: March 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Ulcerative Colitis
• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Asacol®
400mg tablets
• Mesalazine
400mg tablets

Locations

Country	Name	City	State
China	Shanghai Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Tillotts Pharma AG	Zeria Pharmaceutical

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction degree of UC-DAI		Week 8	No
Secondary	1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate		Week 8	Yes