Pharmacogenetics of Gastrointestinal Bleeding
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|ClinicalTrials.gov Identifier: NCT00190255|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Hemorrhage Stomach Ulcer Non-steroidal Anti-inflammatory Drug Sensitivity||Procedure: CY2PC9 genotyping||Phase 4|
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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-inflammatory Drugs : the Role of Cytochrome P450 2C9|
|Study Start Date :||April 2004|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2007|
Procedure: CY2PC9 genotyping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|