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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976690
First Posted: September 14, 2009
Last Update Posted: August 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  Purpose
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.

Condition Intervention Phase
Crohn Disease Drug: Azathioprine OR Mesalazine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • Clinically and endoscopically recurrence at 12 and 24 months [ Time Frame: 12 and 24 months ]

Enrollment: 83
Study Start Date: October 2002
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Azathioprine : 2mg/kg/day
Drug: Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
Active Comparator: 2
Mesalazine : 4g/day
Drug: Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976690


Locations
France
Chu Amiens
Amiens, France, 80054
Chu Besancon
Besancon, France, 25030
CHU CAEN
Caen, France, 14033
Hopital Beaujon
Clichy, France, 92110
Chru Lille
Lille, France, 59037
Hopital Lariboisiere
Paris, France, 75010
Hopital Saint Louis
Paris, France, 75010
Hopital St Antoine
Paris, France, 75012
Hopital Cochin
Paris, France, 75014
Hopital Haut Leveque
Pessac, France, 33604
Chu Reims
Reims, France, 51000
Chu Rennes
Rennes, France, 35033
Chu Toulouse
Toulouse, France, 31403
Chu Tours
Tours, France, 37044
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
Principal Investigator: Marc LEMANN, MD,PhD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  More Information

Additional Information:
Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT00976690     History of Changes
Other Study ID Numbers: GETAID 2001-1
First Submitted: September 11, 2009
First Posted: September 14, 2009
Last Update Posted: August 31, 2011
Last Verified: August 2011

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Crohn's Disease
Ileocolic resection
Endoscopic recurrence
Ileocolic or colon resection (>50cm)

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Azathioprine
Mesalamine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents