Crohn Disease Clinical Trial
— IMURELPOSTOfficial title:
A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
Status | Completed |
Enrollment | 83 |
Est. completion date | December 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Chu Amiens | Amiens | |
France | Chu Besancon | Besancon | |
France | CHU CAEN | Caen | |
France | Hopital Beaujon | Clichy | |
France | Chru Lille | Lille | |
France | Hopital Cochin | Paris | |
France | Hopital Lariboisiere | Paris | |
France | Hopital Saint Louis | Paris | |
France | Hopital St Antoine | Paris | |
France | Hopital Haut Leveque | Pessac | |
France | Chu Reims | Reims | |
France | Chu Rennes | Rennes | |
France | Chu Toulouse | Toulouse | |
France | Chu Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinically and endoscopically recurrence at 12 and 24 months | 12 and 24 months | No |
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