Trial | NCT00976690  Report issue

Title

Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    83
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
Study Started
Oct 31
2002
Primary Completion
Oct 31
2010
Study Completion
Dec 31
2010
Last Update
Aug 31
2011
Estimate

Drug Azathioprine OR Mesalazine

Azathioprine : 2mg/kg/day Mesalazine : 4g/day

1 Active Comparator

Azathioprine : 2mg/kg/day

2 Active Comparator

Mesalazine : 4g/day

Criteria 

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)
No Results Posted