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

NCT01257399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2013-04-04

No results posted yet for this study

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.

Conditions

  • Ulcerative Colitis in Remission

Interventions

DRUG

Asacol®

400 mg tablets

DRUG

Mesalazine

400mg tablets

Sponsors & Collaborators

  • Zeria Pharmaceutical

    collaborator INDUSTRY

  • Tillotts Pharma AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257399 on ClinicalTrials.gov