Study of Acetaminophen (ACM) in Post-operative Dental Pain

A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02735122

Enrollment

420

Registered

2016-04-12

Start date

2016-04-30

Completion date

2016-10-05

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Dental Pain

Brief summary

This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

Detailed description

This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Interventions

DRUGacetaminophen Tablet

2 test acetaminophen 500 mg tablets

DRUGacetaminophen Caplet

2 commercial acetaminophen 500 mg caplets

DRUGibuprofen Liquid-filled capsule

2 commercial ibuprofen 200 mg Liquid-filled capsules

DRUGPlacebo Tablet

2 placebo tablets

DRUGPlacebo Caplet

2 placebo caplets

DRUGPlacebo Liquid-filled capsule

2 placebo Liquid-filled capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 50 Years

Healthy volunteers

Inclusion criteria

1. 17 years to 50 years old 2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive 3. Dental extraction of three or four molars 4. Experience moderate to severe pain after extraction of third molars 5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion criteria

1. Currently pregnant or planning to be pregnant or nursing a baby 2. Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS) 3. Inability to swallow whole large tablets or capsules 4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Design outcomes

Primary

Measure	Time frame	Description
Time to first confirmed perceptible pain relief	6 hours	Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.

Secondary

Measure	Time frame	Description
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)	10 minutes or less	The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)	15 minutes or less	The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)	30 minutes or less	—
Percentage of subjects with meaningful relief by 30 minutes	30 minutes or less	—
Time to meaningful pain relief	6 hours	Minutes until meaningful pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)	20 minutes or less	The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026