Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257386

Enrollment

251

Registered

2010-12-09

Start date

2010-11-30

Completion date

2013-03-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGAsacol®

400mg tablets

DRUGMesalazine

400mg tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction degree of UC-DAI	Week 8

Secondary

Measure	Time frame
1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate	Week 8

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026