Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
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 non-steroidal anti-inflammatory
(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
piroxicam 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, 60 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. For the pharmacokinetics, saliva samples
will be collected at various times according to protocols available in the literature, and
piroxicam concentrations in the samples will be measured by high pressure liquid
chromatography (HPLC) and Liquid chromatography-mass spectrometry (LC MS/MS). The analysis of
the results will be described with a significance level of 0.05.
Phase:
Phase 4
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo