Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

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

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Study Overview

• Status: Completed
• Conditions: Post-operative Dental Pain
• Intervention / Treatment: Drug: Test acetaminophen; Drug: Commercial acetaminophen; Drug: Commercial ibuprofen; Drug: Placebo

Detailed Description

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

• Study Type: Interventional
• Enrollment (Actual): 664
• Phase: Phase 3

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. 17 to 50 years old
2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
3. Dental extraction of three or four third molars
4. Meets post-surgical pain criteria
5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

1. Currently pregnant or planning to be pregnant or nursing a baby
2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
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
5. Use of pain medications 5 or more times per week
6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years
7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
8. Have a positive urine drug screen

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
Experimental: Test acetaminophen; Test acetaminophen 1000 mg dose	Drug: Test acetaminophen; single dose of 2 Test acetaminophen 500 mg tablets; Other Names: Test ACM
Active Comparator: Commercial acetaminophen; Commercial acetaminophen 1000 mg dose	Drug: Commercial acetaminophen; single dose of 2 acetaminophen 500 mg caplets; Other Names: Commercial ACM
Active Comparator: Commercial ibuprofen; Commercial ibuprofen, 400 mg dose	Drug: Commercial ibuprofen; Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules; Other Names: Commercial IBU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Confirmed Perceptible Pain Relief	Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.	within 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Meaningful Pain Relief	Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.	Within 4 hours
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes	Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 30 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes	Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 29 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes	Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 28 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes	Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 27 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes	Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 26 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes	Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 25 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes	Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 24 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes	Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 23 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes	Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 22 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes	Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 21 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes	Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 20 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes	Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 19 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes	Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 18 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes	Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 17 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes	Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 16 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes	Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 15 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes	Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 14 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes	Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 13 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes	Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 12 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes	Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.	by 11 minutes

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Collaborators: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Principal Investigator: Derek Muse, Jean Brown Research/ BB Holdings

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): April 12, 2018

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: April 1, 2019

More Information

Terms related to this study

• 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-170317095828-PACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: YODA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No