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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00946946
Date of registration: 24/07/2009
Prospective Registration: No
Primary sponsor: Dr. Falk Pharma GmbH
Public title: Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
Scientific 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
Date of first enrolment: February 2002
Target sample size: 78
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00946946
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  Phase 3
Countries of recruitment
Austria Germany
Contacts
Name:     Walter Reinisch, Prof
Address: 
Telephone:
Email:
Affiliation:  Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Mesalazine
Drug: Mesalazine placebo
Drug: Azathioprine placebo
Drug: Azathioprine
Primary Outcome(s)
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(s)
adverse events [Time Frame: 12 months]
change in CDAI score [Time Frame: 12 months]
endoscopic improvement at month 12, defined as =1 point reduction in Rutgeerts' score. [Time Frame: 12 months]
Secondary ID(s)
AZT-2/CDP
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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