Trial Outcomes & Findings for Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery (NCT NCT02450487)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

105 participants

Primary outcome timeframe

at 24 hours after surgery

Results posted on

2020-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Interventional Group 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery Piroxicam: After extraction of at least one third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control, collected saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) were analyzed. For the pharmacokinetics of piroxicam saliva samples were 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).
Overall Study STARTED	105
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Interventional Group 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery Piroxicam: After extraction of at least one third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control, collected saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) were analyzed. For the pharmacokinetics of piroxicam saliva samples were 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).
Overall Study Lost to Follow-up	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Group n=102 Participants 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery Piroxicam: After extraction of at least one third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control, collected saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) were analyzed. For the pharmacokinetics of piroxicam saliva samples were 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).
Age, Continuous	24 years STANDARD_DEVIATION 7 • n=102 Participants
Sex: Female, Male Female	76 Participants n=102 Participants
Sex: Female, Male Male	26 Participants n=102 Participants
Region of Enrollment Brazil	102 participants n=102 Participants

PRIMARY outcome

Timeframe: at 24 hours after surgery

Population: Pain control was measure at 24h after surgery

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

Outcome measures

Outcome measures
Measure	Interventional Group n=102 Participants After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control
Score of Pain Measured by Visual Analogue Scale	25 score on a scale (mm) Standard Deviation 25

SECONDARY outcome

Timeframe: Seven days after surgery

Population: Throughout the entire study, only two volunteers reported adverse side effects; on the second day, one volunteer reported sleepiness (CYP2C8\*3 mt and CYP2C9\*1/\*3 genotype) and one volunteer (CYP2C8\*3 mt and CYP2C9\*1/\*3 genotype) reported stomachaches.

Report of adverse effects during the postoperative period until suture removal seven days after extraction of third molar included and/or impacted in patients underwent surgery.

Outcome measures

Outcome measures
Measure	Interventional Group n=102 Participants After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control
Number of Participants With Adverse Events	2 Participants

Adverse Events

Interventional Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interventional Group n=102 participants at risk After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control.
Gastrointestinal disorders Stomachaches	0.98% 1/102 • Number of events 1 • 7 days post-operatively sleepiness and stomachaches.
Nervous system disorders Sleepness	0.98% 1/102 • Number of events 1 • 7 days post-operatively sleepiness and stomachaches.

Additional Information

Dr. Adriana Calvo

Bauru School of Dentistry University of Sao Paulo

Phone: +551432358200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place