Pharmacogenetics of Gastrointestinal Bleeding
|Gastrointestinal Hemorrhage Stomach Ulcer Non-steroidal Anti-inflammatory Drug Sensitivity||Procedure: CY2PC9 genotyping||Phase 4|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-inflammatory Drugs : the Role of Cytochrome P450 2C9|
|Study Start Date:||April 2004|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Procedure: CY2PC9 genotyping
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 of most NSAIDs. Several polymorphisms have been observed in CYP2C9. Of these, the CYP2C9*3 allele, found in 12% of caucasian subjects, leads to reduced function of the enzyme.
We hypothesized that individuals carrying this mutation should be at higher risk of gastrointestinal bleeding since they display decreased elimination of some NSAIDs.
The purpose of this study is to determine whether the frequency for CYP2C9*3 variant allele is increased in subjects using NSAIDs metabolized by CYP2C9 in comparison with subjects under NSAIDs not metabolized by this enzyme.
The study groups consist of 200 patients suffering from gastrointestinal bleeding after NSAIDs use, divided in 100 patients using NSAIDs metabolized by CYP2C9 and 100 patients using other NSAIDs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190255
|Service d'hépato-gastroentérologie, Hôpital Saint Antoine|
|Paris, France, 75012|
|Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière|
|Paris, France, 75013|
|: Service d'hépato-gastroentérologie, Hôpital Henri Mondor|
|Paris, France, 94010|
|Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE|
|Villejuif, France, 94804|
|Principal Investigator:||Nicolas CARBONNELL, MD||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Laurent BECQUEMONT, MD||Assistance Publique - Hôpitaux de Paris|