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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00976690
Acronym
IMURELPOST
Enrollment
83
Registered
2009-09-14
Start date
2002-10-31
Completion date
2010-12-31
Last updated
2011-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn's Disease, Ileocolic resection, Endoscopic recurrence, Ileocolic or colon resection (>50cm)

Brief summary

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

Interventions

DRUGAzathioprine OR Mesalazine

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

Sponsors

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Clinically and endoscopically recurrence at 12 and 24 months12 and 24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026