Status:
COMPLETED
Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
Eligibility Criteria
Inclusion
- more than 18 years old
- 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
- Intolerance to one of both study treatment
- Liver failure (TP\<60%)
- Renal Failure (Creatinine \< Lab results)
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00976690
Start Date
October 1 2002
End Date
December 1 2010
Last Update
August 31 2011
Active Locations (14)
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1
Chu Amiens
Amiens, France, 80054
2
Chu Besancon
Besançon, France, 25030
3
CHU CAEN
Caen, France, 14033
4
Hopital Beaujon
Clichy, France, 92110