NCT00976690

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 31, 2011

Status Verified

August 1, 2011

Enrollment Period

8 years

First QC Date

September 11, 2009

Last Update Submit

August 30, 2011

Conditions

Crohn Disease

Keywords

Crohn's DiseaseIleocolic resectionEndoscopic recurrenceIleocolic or colon resection (>50cm)

Outcome Measures

Primary Outcomes (1)

  • Clinically and endoscopically recurrence at 12 and 24 months

    12 and 24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Azathioprine : 2mg/kg/day

Drug: Azathioprine OR Mesalazine

2

ACTIVE COMPARATOR

Mesalazine : 4g/day

Drug: Azathioprine OR Mesalazine

Interventions

Azathioprine OR MesalazineDRUG

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18 years old
  • Resection \> 50cm or subtotal colectomy with ileorectal anastomosis

You may not qualify if:

  • Intolerance to one of both study treatment
  • Liver failure (TP\<60%)
  • Renal Failure (Creatinine \< Lab results)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Chu Amiens

Amiens, 80054, France

Location

Chu Besancon

Besançon, 25030, France

Location

CHU CAEN

Caen, 14033, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Chru Lille

Lille, 59037, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital St Antoine

Paris, 75012, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Chu Reims

Reims, 51000, France

Location

Chu Rennes

Rennes, 35033, France

Location

Chu Toulouse

Toulouse, 31403, France

Location

Chu Tours

Tours, 37044, France

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

AzathioprineMesalamine

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosidesmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Marc LEMANN, MD,PhD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

October 1, 2002

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

August 31, 2011

Record last verified: 2011-08

Locations

FR(14)