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

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

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 Overview

• Status: Completed
• Conditions: Dental Pain
• Intervention / Treatment: Drug: Acetaminophen (ACE) (1000 mg); Drug: Placebo; Drug: Placebo; Drug: Placebo; Drug: Commercial ACE (1000 mg); Drug: Commercial Ibuprofen (IBU) (400 mg)

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 2 placebo caplets for acetaminophen taken orally one time; Drug: Placebo; 2 placebo soft-gels for ibuprofen taken orally one time; Drug: Placebo; 2 placebo tablets for Test acetaminophen taken orally one time
Experimental: Test Acetaminophen (ACE) (1000 mg) and placebo	Drug: Acetaminophen (ACE) (1000 mg); 2 Test ACE 500 mg tablets taken orally one time; Drug: Placebo; 2 placebo caplets for acetaminophen taken orally one time; Drug: Placebo; 2 placebo soft-gels for ibuprofen taken orally one time; Drug: Placebo; 2 placebo tablets for Test acetaminophen taken orally one time
Active Comparator: Commerical ACE (1000 mg) and placebo	Drug: Placebo; 2 placebo caplets for acetaminophen taken orally one time; Drug: Placebo; 2 placebo soft-gels for ibuprofen taken orally one time; Drug: Placebo; 2 placebo tablets for Test acetaminophen taken orally one time; Drug: Commercial ACE (1000 mg); 2 ACE 500 mg caplets taken orally one time
Active Comparator: Commerical Ibuprofen (IBU) (400 mg) and placebo	Drug: Placebo; 2 placebo caplets for acetaminophen taken orally one time; Drug: Placebo; 2 placebo soft-gels for ibuprofen taken orally one time; Drug: Placebo; 2 placebo tablets for Test acetaminophen taken orally one time; Drug: Commercial Ibuprofen (IBU) (400 mg); 2 IBU 200 mg soft-gels taken orally one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Duration of relief after dosing (time to rescue analgesic)	Minutes until rescue medication is given	6 Hours
Proportion of subjects taking a rescue analgesic by 6 hours	Percentage of subjects using rescue medication through six hours	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	6 Hours

Collaborators and Investigators

• Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• Collaborators: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Study Director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2014
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): April 30, 2015

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: CO-140128120904-PACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided