Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam

University of Sao Paulo

Status and phase

Completed

Phase 4

Conditions

Molar, Third

Pain

Treatments

Drug: Tenoxicam

Study type

Interventional

Funder types

Other

Identifiers

NCT04182191

66699717.3.3001.5417

Details and patient eligibility

About

The goal of this study is to evaluate the different gene haplotypes for the clinical efficacy of tenoxicam after third lower molar surgery for pain, edema and trismus, adverse reactions, need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics of the drug between the different gene haplotypes for CYP2C9 that are found in this population

Full description

Pharmacogenetics is an area of Pharmacology that studies the contribution of genetic factors to individual responses to drugs. This branch of science involves the variability in pharmacodynamics and pharmacokinetics through the study of polymorphisms in genes encoding receptors, as well as in drug metabolism, where this area of Pharmacology has been growing and achieving its first results with clinical use. The NSAIDS are metabolized by cytochrome P450 (CYP) family, predominantly CYP2C9. The goal of this study is to evaluate the different gene haplotypes for the clinical efficacy of tenoxicam after third lower molar surgery for pain, edema and trismus, adverse reactions, need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics of the drug between the different gene haplotypes for CYP2C9 that are found in this population. Therefore, 100 patients will be genotyped and phenotyped for this gene and their postoperative data will be confronted with the data found in the Brazilian population. For the analysis of the proposed gene, saliva will be collected and serve as a source of genomic DNA. For the molecular analysis, polymerase chain reaction (PCR) with tests validated and produced by Applied Biosystems® will be performed. The analysis of the results will be described with a significance level of 0.05.

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Impacted lower third molar;
not making use of nonsteroidal anti-inflammatory drugs in the last 7 days;

Exclusion criteria

Local anesthetics allergy;
History of gastrointestinal bleeding or ulcers;
Kidney disease;
Asthma;
Allergy or sensitivity to aspirin or any other anti-inflammatory non-steroid agent;
Pregnant or nursing women;
Patients using antidepressant, diuretic or aspirin;
Patients received antibiotics for 30 days prior to surgery.