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

Phase 2

Completed

Conditions: Dental Pain

Interventions: Drug: Acetaminophen (ACE) (1000 mg)
Drug: Commercial ACE (1000 mg)
Drug: Commercial Ibuprofen (IBU) (400 mg)
Drug: Placebo

Registration Number: NCT02320708

Lead Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 240

Inclusion Criteria

Are 17 to 50 years of age
Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
Dental extraction of three or four third-molars.
Experience moderate to severe pain after extraction of third molars

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Acetaminophen (ACE) (1000 mg) and placebo	Acetaminophen (ACE) (1000 mg)	-
Test Acetaminophen (ACE) (1000 mg) and placebo	Placebo	-
Commerical ACE (1000 mg) and placebo	Commercial ACE (1000 mg)	-
Commerical ACE (1000 mg) and placebo	Placebo	-
Commerical Ibuprofen (IBU) (400 mg) and placebo	Commercial Ibuprofen (IBU) (400 mg)	-
Commerical Ibuprofen (IBU) (400 mg) and placebo	Placebo	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)	6 Hours	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

Secondary Outcome Measures

Name	Time	Method
Pain relief (PAR) scores at 6 Hours	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 weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)	4 Hours	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 to meaningful pain relief	Within 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.
Time to first perceptible pain relief	Within 6 Hours	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 to confirmed first perceptible relief	Within 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.
Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)	4 hours	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 weighted sum of pain relief from 0-6 (TOTPAR 0-6)	6 hours	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
Duration of relief after dosing (time to rescue analgesic)	6 Hours	Minutes until rescue medication is given
Proportion of subjects taking a rescue analgesic by 6 hours	6 Hours	Percentage of subjects using rescue medication through six hours
Subject Global Evaluation assessed at hour 6 or at time of rescue	6 hours	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
Pain relief (PAR) scores at 0.25 Hours	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
Pain relief (PAR) scores at 0.5 Hours	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
Pain relief (PAR) scores at 0.75 Hours	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
Pain relief (PAR) scores at 1 Hours	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
Pain relief (PAR) scores at 1.25 Hours	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
Pain relief (PAR) scores at 1.5 Hours	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
Pain relief (PAR) scores at 2 Hours	2 hoursH	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
Pain relief (PAR) scores at 3 Hours	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
Pain relief (PAR) scores at 4 Hours	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
Pain relief (PAR) scores at 5 Hours	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
Pain intensity difference (PID) at 0.5 Hours	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
Pain intensity difference (PID) at 0.75 Hours	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
Pain intensity difference (PID) at 1 Hours	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
Pain intensity difference (PID) at 1.25 Hours	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
Pain intensity difference (PID) at 1.5 Hours	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
Pain intensity difference (PID) at 2 Hours	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
Pain intensity difference (PID) at 3 Hours	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
Pain intensity difference (PID) at 4 Hours	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
Pain intensity difference (PID) at 5 Hours	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
Pain intensity difference (PID) at 6 Hours	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
Pain intensity difference (PID) at 0.25 Hours	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