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

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

Study Overview

• Status: Completed
• Conditions: Pain; Molar, Third
• Intervention / Treatment: Drug: Tenoxicam

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Bauru, Sao Paulo, Brazil, 17012901
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 89 patients will be treated with tenoxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Three days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	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.	Seven days after surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Paulo Zupelari Goncalves, DDS, Ms, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Tenoxicam
• Other Study ID Numbers: 66699717.3.3001.5417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No