Skip to main content
OpenTrials
Completed

NCT Number: NCT02735122

Study of Acetaminophen (ACM) in Post-operative 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Operative Dental Pain

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 17 years to 50 years old
  • Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
  • Dental extraction of three or four molars
  • Experience moderate to severe pain after extraction of third molars
  • Females of childbearing age must be willing to use acceptable method of birth control

Exclusion criteria

  • Currently pregnant or planning to be pregnant or nursing a baby
  • Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
  • Inability to swallow whole large tablets or capsules
  • Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Treatment and study plan

acetaminophen Tablet

Drug

2 test acetaminophen 500 mg tablets

Other names: Test ACM

acetaminophen Caplet

Drug

2 commercial acetaminophen 500 mg caplets

Other names: Commercial ACM

ibuprofen Liquid-filled capsule

Drug

2 commercial ibuprofen 200 mg Liquid-filled capsules

Other names: Commercial IBU

Placebo Tablet

Drug

2 placebo tablets

Placebo Caplet

Drug

2 placebo caplets

Placebo Liquid-filled capsule

Drug

2 placebo Liquid-filled capsules

Primary outcomes

  1. Time to first confirmed perceptible pain relief

    Time frame: 6 hours

    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.

Secondary outcomes

  1. Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)

    Time frame: 30 minutes or less

  2. Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)

    Time frame: 10 minutes or less

    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

  3. Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)

    Time frame: 15 minutes or less

    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

  4. Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)

    Time frame: 20 minutes or less

    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

  5. Percentage of subjects with meaningful relief by 30 minutes

    Time frame: 30 minutes or less

  6. Time to meaningful pain relief

    Time frame: 6 hours

    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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Industry

Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.