Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery
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|ClinicalTrials.gov Identifier: NCT02450487|
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain Other Surgical Procedures Impacted Third Molar Tooth Cytochrome P450 CYP2C9 Enzyme Deficiency||Drug: Piroxicam||Phase 4|
Lower third molars (with high degree of difficulty) surgeries will be performed in Clinical Pharmacology Laboratory at the Bauru School of Dentistry - University of São Paulo (FOB-USP), which will be provided to patients daily doses of piroxicam 20 mg 4 days. Thus collect data related to pain, swelling, trismus, amount of rescue medication required by patients, overall assessment and satisfaction about taking medicine, saliva samples for the analysis of the pharmacokinetics of the drug, genotyping and phenotyping of the subjects of the research.
The global clinical evaluation along with genotyping and phenotyping these individuals can show us if there is an influence not only in adverse effects, but also in the therapeutic effects of the drug in the Brazilian population. Research of this nature are rare in this area of Clinical Pharmacogenetics and can be of great help in prescribing these drugs to control pain and inflammation.After the removal of third molars will make collecting 6 mL of saliva in several post-surgical moments for analysis of the pharmacokinetics of the drug piroxicam and 10 mL of saliva for the analysis of genetic material. It is noteworthy that this project will initiate the nucleation of a new line of research in college, the first in Pharmacogenetics area conducted in FOB / USP.Will be assessed the following parameters in all patients after surgery of at least a third lower molar with a high degree of difficulty (Annexes 1, 2 and 3): 1) onset and duration of surgery after the administration of the local anesthetic, 2) open mouth prior to surgery, on the 2nd day after the surgery and on the 7th day after surgery (removal of stitches); 3) measured the facial edema in the second day after surgery and on the 7th day after surgery (compared to the measurements obtained before surgery); 4) body temperature before surgery, on the 2nd day after the operation and on the 7th day after surgery (removal of stitches); 5) incidence, type and severity of adverse reactions, 6) plug pain (VAS - visual analog scale) filled by patients for 4 days after prescription Piroxicam; 7) amount of rescue medication required by patients.
The comparative analysis of the data, along with data on the pharmacokinetics of the drug, genotyping and phenotyping the CYP2C9 gene, provide the basis for evaluation of the influence of the gene in clinical efficacy, side effects and need for relief medication required by patients after surgery third- molars with a high degree of difficulty, which was prescribed as anti-inflammatory piroxicam.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Influence of Genotype of Cytochrome P450 (CYP2C9) on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Interventional group
100 patients will be treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery
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).
- Reduction of pain measured by visual analogue scale [ Time Frame: Seven days after surgery ]Reducing 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.
- Adverse effects [ Time Frame: Seven days after surgery ]Increased 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450487
|Study Chair:||Adriana M Calvo, PhD||Bauru School of Dentistry/University of Sao Paulo|