Pharmacogenetics of Gastrointestinal Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

NCT05572593

Gastrointestinal Diseases

COMPLETED NA

Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population

NCT05071742

Gene Abnormality Inflammatory Bowel Disease Chinese

UNKNOWN

Pharmacogenetic Testing and Chronic Pain

NCT05259865

Chronic Pain

SUSPENDED

Utility of PharmacoGenomics for Reducing Adverse Drug Effects

NCT02081872

Genetics of Drug Metabolism

UNKNOWN

Pharmacogenomics of Antidepressant Response in Children and Adolescents

NCT00516932

Anxiety Disorders Depression Eating Disorders +2 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Hemorrhage Stomach Ulcer Non-steroidal Anti-inflammatory Drug Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CY2PC9 genotyping

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No