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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946946
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Azathioprine Drug: Mesalazine Drug: Azathioprine placebo Drug: Mesalazine placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2002
Actual Primary Completion Date : May 2007
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Azathioprine
2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets
Drug: Azathioprine
2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
Other Name: Azafalk 50mg tablets

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

Active Comparator: Mesalazine
4g mesalazine tablets/day AND azathioprine placebo tablets
Drug: Mesalazine
4g Mesalazine tablets/day AND azathioprine placebo tablets
Other Name: Salofalk 500mg tablets

Drug: Azathioprine placebo
4g Mesalazine tablets/day AND azathioprine placebo tablets

Primary Outcome Measures :
  1. The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. endoscopic improvement at month 12, defined as ≥1 point reduction in Rutgeerts' score. [ Time Frame: 12 months ]
  2. change in CDAI score [ Time Frame: 12 months ]
  3. adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,
  • Scheduled or intended active immunisation with living vaccines within the next 12 months,
  • Well-founded doubt about the patient's cooperation,
  • Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 15 months,
  • Non-use of appropriate contraceptives in males with procreative capacity and females of childbearing potential (e.g. condoms for males, intrauterine device [IUD], hormonal contraception for females, or a means of contraception for a particular patient considered adequate by the responsible investigator) during treatment and within 3 months after the end of treatment,
  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial,
  • Present stricture plasty (no exclusion if the present stricture plasty was macroscopically without any relevant finding of inflammation seen during index surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946946

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Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie
Vienna, Austria, 1090
Robert-Bosch Krankenhaus, Innere Medizin I
Stuttgart, Germany, Postfach 501120
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Principal Investigator: Walter Reinisch, Prof Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria

Publications of Results:
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00946946     History of Changes
Other Study ID Numbers: AZT-2/CDP
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Dr. Falk Pharma GmbH:
Crohn's Disease

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents