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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Azathioprine OR Mesalazine
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, Ileocolic resection, Endoscopic recurrence, Ileocolic or colon resection (>50cm)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chu Amiens
  • Chu Besancon
  • CHU CAEN
  • Hopital Beaujon
  • Chru Lille
  • Hopital Lariboisiere
  • Hopital Saint Louis
  • Hopital St Antoine
  • Hopital Cochin
  • Hopital Haut Leveque
  • Chu Reims
  • Chu Rennes
  • Chu Toulouse
  • Chu Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Azathioprine : 2mg/kg/day

Mesalazine : 4g/day

Outcomes

Primary Outcome Measures

Clinically and endoscopically recurrence at 12 and 24 months

Secondary Outcome Measures

Full Information

First Posted
September 11, 2009
Last Updated
August 30, 2011
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT00976690
Brief Title
Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Acronym
IMURELPOST
Official Title
A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's Disease, Ileocolic resection, Endoscopic recurrence, Ileocolic or colon resection (>50cm)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Azathioprine : 2mg/kg/day
Arm Title
2
Arm Type
Active Comparator
Arm Description
Mesalazine : 4g/day
Intervention Type
Drug
Intervention Name(s)
Azathioprine OR Mesalazine
Intervention Description
Azathioprine : 2mg/kg/day Mesalazine : 4g/day
Primary Outcome Measure Information:
Title
Clinically and endoscopically recurrence at 12 and 24 months
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc LEMANN, MD,PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Chu Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital St Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
Chu Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Chu Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.getaid.org
Description
Related Info

Learn more about this trial

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

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