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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
2 test acetaminophen 500 mg tablets
2 commercial acetaminophen 500 mg caplets
2 commercial ibuprofen 200 mg Liquid-filled capsules
Jean Brown Research
Salt Lake City, Utah, United States
Time to first confirmed perceptible pain relief
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.
Time frame: 6 hours
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)
Time frame: 30 minutes or less
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)
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
Time frame: 10 minutes or less
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)
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
Time frame: 15 minutes or less
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)
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
Time frame: 20 minutes or less
Percentage of subjects with meaningful relief by 30 minutes
Time frame: 30 minutes or less
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2 placebo tablets
2 placebo caplets
2 placebo Liquid-filled capsules
Time to meaningful pain relief
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.
Time frame: 6 hours