Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

Crohn Disease Clinical Trial

— IMURELPOST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976690
• Other study ID #: GETAID 2001-1
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2009
• Last updated: August 30, 2011
• Start date: October 2002
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Recurrence

Intervention

Drug:
• Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically and endoscopically recurrence at 12 and 24 months		12 and 24 months	No

External Links

•   Link