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

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.
 
ClinicalTrials.gov Identifier: NCT00976690
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date August 31, 2011
Study Start Date  ICMJE October 2002
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Clinically and endoscopically recurrence at 12 and 24 months [ Time Frame: 12 and 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Official Title  ICMJE A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Brief Summary To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE Drug: Azathioprine OR Mesalazine
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
Study Arms  ICMJE
  • Active Comparator: 1
    Azathioprine : 2mg/kg/day
    Intervention: Drug: Azathioprine OR Mesalazine
  • Active Comparator: 2
    Mesalazine : 4g/day
    Intervention: Drug: Azathioprine OR Mesalazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2011)
83
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2009)
96
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976690
Other Study ID Numbers  ICMJE GETAID 2001-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Sponsor  ICMJE Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc LEMANN, MD,PhD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
PRS Account Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP