Phase 4 N=105 Supportive Care

Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery

Pain · Other Surgical Procedures · Impacted Third Molar Tooth · Cytochrome P450 CYP2C9 Enzyme Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT02450487 ↗

Enrolled (actual)

105

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Score of Pain Measured by Visual Analogue Scale — 25 score on a scale (mm)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Piroxicam (Drug)
Age: Pediatric, Adult · 17+ yrs
Sex: All
Sponsor: University of Sao Paulo
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Score of Pain Measured by Visual Analogue Scale	25	—
SECONDARY Number of Participants With Adverse Events	2	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02450487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.