Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
- Registration Number
- NCT00976690
- Lead Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Brief Summary
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
- 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 Criteria
- Intolerance to one of both study treatment
- Liver failure (TP<60%)
- Renal Failure (Creatinine < Lab results)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Azathioprine OR Mesalazine Mesalazine : 4g/day 1 Azathioprine OR Mesalazine Azathioprine : 2mg/kg/day
- Primary Outcome Measures
Name Time Method Clinically and endoscopically recurrence at 12 and 24 months 12 and 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Chu Amiens
🇫🇷Amiens, France
Hopital Haut Leveque
🇫🇷Pessac, France
Chu Reims
🇫🇷Reims, France
Chu Besancon
🇫🇷Besancon, France
CHU CAEN
🇫🇷Caen, France
Hopital Beaujon
🇫🇷Clichy, France
Chru Lille
🇫🇷Lille, France
Chu Rennes
🇫🇷Rennes, France
Hopital Lariboisiere
🇫🇷Paris, France
Hopital Saint Louis
🇫🇷Paris, France
Hopital St Antoine
🇫🇷Paris, France
Hopital Cochin
🇫🇷Paris, France
Chu Tours
🇫🇷Tours, France
Chu Toulouse
🇫🇷Toulouse, France