NCT04182191

Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam

Influence of Cytochrome P450 (CYP2C9) Genotype on Clinical Efficacy of Tenoxicam After Lower Third Molars Surgeries

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Molar, Third
• Pain

Interventions

Type	Name	Description
DRUG	Tenoxicam	After extraction of at least one third molar, 89 patients will be treated with tenoxicam (20 mg once daily for 4 days) for pain control, collect the saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) will be analyzed.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-07-01
• Completion: 2019-11-01
• First posted: 2019-12-02
• Last updated: 2019-12-02

Locations

1 site across 1 country: Brazil