Dental Pain
Conditions
Keywords
Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
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.
Interventions
DRUGAcetaminophen (ACE) (1000 mg)
2 Test ACE 500 mg tablets taken orally one time
DRUGCommercial ACE (1000 mg)
2 ACE 500 mg caplets taken orally one time
DRUGCommercial Ibuprofen (IBU) (400 mg)
2 IBU 200 mg soft-gels taken orally one time
DRUGPlacebo
2 placebo caplets for acetaminophen taken orally one time
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
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
No
Inclusion criteria
1. Are 17 to 50 years of age 2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive) 3. Dental extraction of three or four third-molars. 4. Experience moderate to severe pain after extraction of third molars
Exclusion criteria
1. Currently pregnant (or planning to be pregnant) or nursing a baby 2. Known allergy to acetaminophen (ACE) 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed