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

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

This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

Study Overview

• Status: Completed
• Conditions: Post Operative Dental Pain
• Intervention / Treatment: Drug: acetaminophen Tablet; Drug: Placebo Caplet; Drug: Placebo Liquid-filled capsule; Drug: acetaminophen Caplet; Drug: Placebo Tablet; Drug: ibuprofen Liquid-filled capsule

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 420
• 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: 15 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 17 years to 50 years old
2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
3. Dental extraction of three or four molars
4. Experience moderate to severe pain after extraction of third molars
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 (ACM) 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
Experimental: Test acetaminophen; acetaminophen tablet and placebo caplet and placebo liquid-filled capsule	Drug: acetaminophen Tablet; 2 test acetaminophen 500 mg tablets; Other Names: Test ACM; Drug: Placebo Caplet; 2 placebo caplets; Drug: Placebo Liquid-filled capsule; 2 placebo Liquid-filled capsules
Active Comparator: Commercial acetaminophen; acetaminophen caplet and placebo tablet and placebo liquid-filled capsule	Drug: Placebo Liquid-filled capsule; 2 placebo Liquid-filled capsules; Drug: acetaminophen Caplet; 2 commercial acetaminophen 500 mg caplets; Other Names: Commercial ACM; Drug: Placebo Tablet; 2 placebo tablets
Active Comparator: Commercial ibuprofen; ibuprofen liquid-filled capsule and placebo tablet and placebo caplet	Drug: Placebo Caplet; 2 placebo caplets; Drug: Placebo Tablet; 2 placebo tablets; Drug: ibuprofen Liquid-filled capsule; 2 commercial ibuprofen 200 mg Liquid-filled capsules; Other Names: Commercial IBU
Placebo Comparator: Placebo; Placebo tablet and placebo caplet and placebo liquid-filled capsule	Drug: Placebo Caplet; 2 placebo caplets; Drug: Placebo Liquid-filled capsule; 2 placebo Liquid-filled capsules; Drug: Placebo Tablet; 2 placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first confirmed perceptible pain 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.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)		30 minutes or less
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)	The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes	10 minutes or less
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)	The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes	15 minutes or less
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)	The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes	20 minutes or less
Percentage of subjects with meaningful relief by 30 minutes		30 minutes or less
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.	6 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2016
• Primary Completion (Actual): October 5, 2016
• Study Completion (Actual): October 5, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

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-151027203834-PACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.

Drug and device information, study documents

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