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OpenTrials
Completed

NCT Number: NCT00976690

Comparison 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.

Completed

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Azathioprine OR Mesalazine

Drug

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

Primary outcomes

  1. Clinically and endoscopically recurrence at 12 and 24 months

    Time frame: 12 and 24 months

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study title

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

Acronym: IMURELPOST

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2009
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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