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Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

NCT00747110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2012-06-26

No results posted yet for this study

Summary

The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

budesonide

3x 3mg budesonide capsules once daily

DRUG

mesalazine

3x 1000mg mesalazine onc daily

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Ralph Mueller, Dr · Dr. Falk Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-08-31
Completion
2010-08-31

Countries

  • Germany

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 NCT00747110 on ClinicalTrials.gov