Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
NCT ID: NCT00976690
Last Updated: 2011-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2002-10-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Azathioprine : 2mg/kg/day
Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
2
Mesalazine : 4g/day
Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
Interventions
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Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
Eligibility Criteria
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Inclusion Criteria
* Clinical remission at inclusion time (CDAI\<150)
* Having ileocolonic or colon resection 21 days before inclusion
* Resection \> 50cm or subtotal colectomy with ileorectal anastomosis
Exclusion Criteria
* Liver failure (TP\<60%)
* Renal Failure (Creatinine \< Lab results)
18 Years
ALL
No
Sponsors
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Marc LEMANN, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Locations
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Chu Amiens
Amiens, , France
Chu Besancon
Besançon, , France
CHU CAEN
Caen, , France
Hopital Beaujon
Clichy, , France
Chru Lille
Lille, , France
Hopital Lariboisiere
Paris, , France
Hopital Saint Louis
Paris, , France
Hopital St Antoine
Paris, , France
Hopital Cochin
Paris, , France
Hopital Haut Leveque
Pessac, , France
Chu Reims
Reims, , France
Chu Rennes
Rennes, , France
Chu Toulouse
Toulouse, , France
Chu Tours
Tours, , France
Countries
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Related Links
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Related Info
Other Identifiers
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GETAID 2001-1
Identifier Type: -
Identifier Source: org_study_id