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

NCT02450487 | Completed Phase 4 Results DMC

• 1 other identifier: 20657913.7.0000.5417 CAAE
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Piroxicam; Pharmacogenetic; Lower Third molar

Outcome Measures

Primary Outcomes (1)

• Score of Pain Measured by Visual Analogue Scale

  Score of pain after third molar surgery is measured by visual analogue scale (0-100mm).

  at 24 hours after surgery

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Seven days after surgery

Study Arms (1)

Interventional group

EXPERIMENTAL

100 patients will be treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery

Drug: Piroxicam

Interventions

Piroxicam DRUG

After extraction of at least one third molar, 100 patients will be treated with Piroxicam (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. For the pharmacokinetics of piroxicam saliva samples will be collected from 10 of these patients at different times after ingestion of a capsule of 20 mg Piroxicam (before, 1, 2, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hours after ingestion).

Also known as: Lower third molar surgery, Pharmacogenetics

Interventional group

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Impacted lower third molar;
• not making use of nonsteroidal anti-inflammatory drugs in the last 7 days;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Pain

Interventions

Piroxicam; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Adriana Calvo
• Organization: Bauru School of Dentistry University of Sao Paulo

birinjela@yahoo.com.br

+551432358200

Study Officials

• Adriana M Calvo, PhD

  Bauru School of Dentistry/University of Sao Paulo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 21, 2015
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09