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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02320708
Other study ID # CO-140128120904-PACT
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 31, 2014
Est. completion date April 30, 2015

Study information

Verified date November 2021
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date April 30, 2015
Est. primary completion date April 30, 2015
Accepts healthy volunteers No
Gender All
Age group 17 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acetaminophen (ACE) (1000 mg)
2 Test ACE 500 mg tablets taken orally one time
Commercial ACE (1000 mg)
2 ACE 500 mg caplets taken orally one time
Commercial Ibuprofen (IBU) (400 mg)
2 IBU 200 mg soft-gels taken orally one time
Placebo
2 placebo caplets for acetaminophen taken orally one time
Placebo
2 placebo soft-gels for ibuprofen taken orally one time
Placebo
2 placebo tablets for Test acetaminophen taken orally one time

Locations

Country Name City State
United States Jean Brown Research Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 Hours
Secondary 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 4 Hours
Secondary 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. Within 6 Hours
Secondary 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. Within 6 Hours
Secondary 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. Within 6 Hours
Secondary Time weighted sum of pain relief from 0-4 (TOTPAR 0-4) 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 4 hours
Secondary 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 6 hours
Secondary Duration of relief after dosing (time to rescue analgesic) Minutes until rescue medication is given 6 Hours
Secondary Proportion of subjects taking a rescue analgesic by 6 hours Percentage of subjects using rescue medication through six hours 6 Hours
Secondary 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 6 hours
Secondary 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 0.25 Hours
Secondary 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 0.5 Hours
Secondary 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 0.75 Hours
Secondary 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 1 Hours
Secondary 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 1.25 Hours
Secondary 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 1.5 Hours
Secondary 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 2 hoursH
Secondary 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 3 Hours
Secondary 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 4 Hours
Secondary 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 5 Hours
Secondary 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 6 Hours
Secondary 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 0.25 Hours
Secondary 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 0.5 Hours
Secondary 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 0.75 Hours
Secondary 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 1 Hours
Secondary 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 1.25 Hours
Secondary 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 1.5 Hours
Secondary 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 2 Hours
Secondary 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 3 Hours
Secondary 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 4 Hours
Secondary 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 5 Hours
Secondary 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 6 Hours
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