Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam

NCT04182191 | Completed Phase 4 DMC

• 1 other identifier: 66699717.3.3001.5417
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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

Conditions

Molar, Third; Pain

Outcome Measures

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.

  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 Outcomes (1)

• Adverse effects

  Seven days after surgery

Study Arms (1)

Interventional group

EXPERIMENTAL

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

Drug: Tenoxicam

Interventions

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.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Sao Paulo

Bauru, São Paulo, 17012901, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

tenoxicam

Condition Hierarchy (Ancestors)

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

Study Officials

• Paulo Zupelari Goncalves, DDS, Ms

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: March 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)