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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257399

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

Ulcerative Colitis in Remission

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.

Interventions

DRUGAsacol®

400 mg 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 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.

Design outcomes

Primary

Measure	Time frame
Rate of non-emergence of bloody stool	Week 48

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

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