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

August 30, 2011 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

A Multicentre Randomized Open Study Comparing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besancon, France, 25030
        • CHU Besançon
      • Caen, France, 14033
        • CHU Caen
      • Clichy, France, 92110
        • Hopital Beaujon
      • Lille, France, 59037
        • CHRU Lille
      • Paris, France, 75010
        • Hôpital Saint Louis
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75012
        • Hopital St Antoine
      • Pessac, France, 33604
        • Hôpital Haut Lévêque
      • Reims, France, 51000
        • CHU Reims
      • Rennes, France, 35033
        • CHU Rennes
      • Toulouse, France, 31403
        • CHU Toulouse
      • Tours, France, 37044
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinically and endoscopically recurrence at 12 and 24 months
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Marc LEMANN, MD,PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2001-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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