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Completed

NCT Number: NCT04182191

Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo

Bauru, São Paulo, 17012901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenoxicam

Drug

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.

Primary outcomes

  1. Change of pain measured by visual analogue scale on periods of 0, 025, 05, 0,75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours after surgery.

    Time frame: Three days after surgery

    Change of pain after third molar surgery is measured by visual analogue scale. It is expected that the visual analogue scale 100mm present lower values in patients heterozygous and mutated for the CYP2C9 the evaluated periods of 0, 15, 30,45 min, 1, 2, 3, 4, 5, 6, 8, 12, 16 , 24 48 and 72 hours after surgery. Lower values on this scale means lower pain suffered by the volunteers.

Secondary outcomes

  1. Adverse effects

    Time frame: Seven days after surgery

    Changes on reporting of adverse effects during the postoperative period until suture removal seven days after extraction of third molar included and/or impacted in patients heterozygous or mutated for CYP2C9 assessed by the information contained in the medical records of the patient.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2019
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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