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Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

NCT00946946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2012-06-26

No results posted yet for this study

Summary

This study aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe endoscopic recurrence.

Conditions

Interventions

DRUG

Azathioprine

2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

DRUG

Mesalazine

4g Mesalazine tablets/day AND azathioprine placebo tablets

DRUG

Azathioprine placebo

4g Mesalazine tablets/day AND azathioprine placebo tablets

DRUG

Mesalazine placebo

2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Walter Reinisch, Prof · Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2007-05-31
Completion
2009-07-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT00946946 on ClinicalTrials.gov