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9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

NCT01086553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2014-10-30

No results posted yet for this study

Summary

This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.

Conditions

  • Crohn´s Disease

Interventions

DRUG

budesonide

9mg budesonide OD

DRUG

budesonide

3mg budesonide TID

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Axel Dignass, Prof. · Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken

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
2009-11-30
Primary Completion
2012-05-31
Completion
2012-12-31

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 NCT01086553 on ClinicalTrials.gov