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Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT04182191
Collaborator
(none)
89
Enrollment
1
Location
1
Arm
20
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Influence of Cytochrome P450 (CYP2C9) Genotype on Clinical Efficacy of Tenoxicam After Lower Third Molars Surgeries
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  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. [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 Outcome Measures

  1. Adverse effects [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Sao Paulo Bauru Sao Paulo Brazil 17012901

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • Principal Investigator: Paulo Zupelari Goncalves, DDS, Ms, University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paulo Zupelari Goncalves, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT04182191
Other Study ID Numbers:
  • 66699717.3.3001.5417
First Posted:
Dec 2, 2019
Last Update Posted:
Dec 2, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Tenoxicam

Study Results

No Results Posted as of Dec 2, 2019