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| Sponsor: | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
|---|---|
| Information provided by (Responsible Party): | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| ClinicalTrials.gov Identifier: | NCT00976690 |
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 III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 St Antoine | |
| Paris, France, 75012 | |
| Hopital Saint Louis | |
| Paris, France, 75010 | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Hopital Lariboisiere | |
| Paris, France, 75010 | |
| 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 | |
| Principal Investigator: | Marc LEMANN, MD,PhD | GETAID |
More 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 |
| Study First Received: | September 11, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Crohn's Disease Ileocolic resection Endoscopic recurrence Ileocolic or colon resection (>50cm) |
|
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 Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses 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 Central Nervous System Agents |
