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

Ulcerative Colitis in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257399
• Other study ID #: 03010302A
• 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 (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.

Recruitment information / eligibility

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

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis in Remission

Intervention

Drug:
• Asacol®
400 mg 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	Rate of non-emergence of bloody stool		Week 48	No
Secondary	1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score		Week 48	Yes