An observational study in Gastrointestinal Hemorrhage, Stomach Ulcer and Non-steroidal Anti-inflammatory Drug Sensitivity, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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 several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 200 is close to the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
CY2PC9 genotyping
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris