Status:
COMPLETED
Pharmacogenetics of Gastrointestinal Bleeding
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gastrointestinal Hemorrhage
Stomach Ulcer
Eligibility:
All Genders
18+ years
Brief Summary
Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination o...
Detailed Description
Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination o...
Eligibility Criteria
Inclusion
- Upper gastrointestinal bleeding revealed by hematemesis, melena or lowering of at least 2g/dl of haemoglobin
- Endoscopic report of gastrointestinal ulcer or haemorrhagic lesion
- Immediate antecedents of NSAID therapy
Exclusion
- Cirrhosis (Child B or C)
- Coma
- Concomitant therapy with substrates or inhibitors of CYP2C9 : ketoconazole, itraconazole, ritonavir, phenobarbital, rifampicin, depakine, phenytoin, St John's worts
- Patients treated by a NSAID metabolized by CYP2C9 and a NSAID not metabolized by CYP2C9
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00190255
Start Date
April 1 2004
End Date
July 1 2007
Last Update
May 10 2011
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Service d'hépato-gastroentérologie, Hôpital Saint Antoine
Paris, France, 75012
2
Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière
Paris, France, 75013
3
: Service d'hépato-gastroentérologie, Hôpital Henri Mondor
Paris, France, 94010
4
Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE
Villejuif, France, 94804