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Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence

NCT00946946•Dr. Falk Pharma GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent,
•Man or woman between 18 and 70 years of age,
•Diagnosis of Crohn's disease confirmed by endoscopic and histological, or endoscopic and radiological criteria within one year or by histopathological criteria during resection,
•Clinical remission defined as Crohn´s Disease Activity Index (CDAI) \< 200, within the last two weeks. No clinical relapse due to Crohn's disease since resection,
•Moderate (i2a) or severe endoscopic recurrence (i3-i4) within 6 to 24 months after curative resection of the terminal ileum and partial colectomy with ileocolonic resection for complications of ileal Crohn´s disease and with a construction of an ileocolonic anastomosis,
•Within the neoterminal ileum at least more than 5 aphthous lesions with normal mucosa between the lesions, or skip areas of larger lesions,
•Negative pregnancy test at screening visit in females of childbearing potential,
•Use of appropriate contraceptive methods for females of childbearing potential and males with procreative capacity during treatment and at least up to 3 months after the end of treatment.

Exclusion Criteria

•Lesions confined to the ileocolonic anastomosis (i.e., \< 1 cm in length)
•Short bowel syndrome,
•Serious secondary illnesses of an acute or chronic nature, which in the opinion of the Investigator renders the patient unsuitable for inclusion into the study,
•Serum creatinine levels exceeding 1.5 mg/dL or 130 umol/L,
•Presence of an ileo-/colonic stoma,
•Genotype: thiopurine methyltransferase (TPMT) -/-,
•Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years),
•Treatment with cytostatics or immunosuppressants, methotrexate, cyclosporine, 6-MP, Azathioprine, 6-TG or anti-TFN-alpha therapy since resection; postoperative treatment with corticosteroids for more than 4 weeks or postoperative treatment with oral antibiotics (e.g., metronidazole, ciprofloxacin) for more than 4 weeks,
•Application of non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Screening visit except low dose acetylsalicylic acid and except paracetamol,
•Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile,
+6 more criteria

Locations (2)

Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie

Vienna, Austria

Robert-Bosch Krankenhaus, Innere Medizin I

Stuttgart, Germany

Key Dates

Start Date

February 1, 2002

Primary Completion Date

May 1, 2007

Completion Date

July 1, 2009

Last Updated

June 26, 2012

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Azathioprine

DRUG

Mesalazine

DRUG

Azathioprine placebo

DRUG

Mesalazine placebo

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease