This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
2 Test ACE 500 mg tablets taken orally one time
2 ACE 500 mg caplets taken orally one time
2 IBU 200 mg soft-gels taken orally one time
Jean Brown Research
Salt Lake City, Utah, United States
Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 6 Hours
Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)
Time weighted sum of pain intensity difference scores from baseline over 4 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 4 Hours
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: Within 6 Hours
Time to first perceptible pain relief
Minutes until first perceptible pain relief is 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.
Time frame: Within 6 Hours
Time to confirmed first perceptible 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: Within 6 Hours
Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)
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2 placebo caplets for acetaminophen taken orally one time
2 placebo soft-gels for ibuprofen taken orally one time
2 placebo tablets for Test acetaminophen taken orally one time
Time weighted sum of pain relief scores over four hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 4 hours
Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)
Time weighted sum of pain relief scores over six hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 6 hours
Duration of relief after dosing (time to rescue analgesic)
Minutes until rescue medication is given
Time frame: 6 Hours
Proportion of subjects taking a rescue analgesic by 6 hours
Percentage of subjects using rescue medication through six hours
Time frame: 6 Hours
Subject Global Evaluation assessed at hour 6 or at time of rescue
Patient assessment of the pain medication - number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent
Time frame: 6 hours
Pain relief (PAR) scores at 0.25 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 0.25 Hours
Pain relief (PAR) scores at 0.5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 0.5 Hours
Pain relief (PAR) scores at 0.75 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 0.75 Hours
Pain relief (PAR) scores at 1 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 1 Hours
Pain relief (PAR) scores at 1.25 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 1.25 Hours
Pain relief (PAR) scores at 1.5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 1.5 Hours
Pain relief (PAR) scores at 2 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 2 hoursH
Pain relief (PAR) scores at 3 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 3 Hours
Pain relief (PAR) scores at 4 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 4 Hours
Pain relief (PAR) scores at 5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 5 Hours
Pain relief (PAR) scores at 6 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time frame: 6 Hours
Pain intensity difference (PID) at 0.25 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 0.25 Hours
Pain intensity difference (PID) at 0.5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 0.5 Hours
Pain intensity difference (PID) at 0.75 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 0.75 Hours
Pain intensity difference (PID) at 1 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 1 Hours
Pain intensity difference (PID) at 1.25 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 1.25 Hours
Pain intensity difference (PID) at 1.5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 1.5 Hours
Pain intensity difference (PID) at 2 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 2 Hours
Pain intensity difference (PID) at 3 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 3 Hours
Pain intensity difference (PID) at 4 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 4 Hours
Pain intensity difference (PID) at 5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 5 Hours
Pain intensity difference (PID) at 6 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time frame: 6 Hours