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

Dental Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320708
• Other study ID #: CO-140128120904-PACT
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dental Pain
• Toothache

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