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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00190255 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Hemorrhage Stomach Ulcer Anti-Inflammatory Agents, Non-Steroidal |
Procedure: CY2PC9 genotyping |
Phase IV |
| Study Type: | Observational |
| Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
| Official Title: | Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-Inflammatory Drugs : the Role of Cytochrome P450 2C9 |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | March 2007 |
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.
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 | |
| Service d’hépato-gastroentérologie, Hôpital Saint Antoine | |
| PARIS, France, 75012 | |
| Service d’hépato-gastroentérologie, Hôpital Européen Georges Pompidou | |
| PARIS, France, 75015 | |
| : Service d’hépato-gastroentérologie, Hôpital Henri Mondor | |
| Paris, France, 94010 | |
| Service d’hépato-gastroentérologie, Hôpital Paul BROUSSE | |
| VILLEJUIF, France, 94804 | |
| Service d’hépato-gastroentérologie, Hôpital Pitié Salpétrière | |
| Paris, France, 75013 | |
| Principal Investigator: | Nicolas CARBONNELL, MD | Assistance Publique - Hôpitaux de Paris |
| Study Director: | Laurent BECQUEMONT, MD | Assistance Publique - Hôpitaux de Paris |
More Information
| Study ID Numbers: | AOR 03043, P030412 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00190255 |
| Health Authority: | France: Ministry of Health |
|
gastrointestinal haemorrhage stomach ulcer anti-inflammatory agents, non-steroidal |
CYP2C9 protein, human genotype pharmacogenetics |
|
Stomach Ulcer Stomach Diseases Digestive System Diseases Gastrointestinal Diseases |
Ulcer Gastrointestinal Hemorrhage Hemorrhage Peptic Ulcer |
|
Pathologic Processes |
