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NCT Number: NCT02320708

Study of Acetaminophen (ACE) in Post-operative 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.

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Key information

Conditions

Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are 17 to 50 years of age
  • Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
  • Dental extraction of three or four third-molars.
  • Experience moderate to severe pain after extraction of third molars

Exclusion criteria

  • Currently pregnant (or planning to be pregnant) or nursing a baby
  • Known allergy to acetaminophen (ACE) 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 (ACE) (1000 mg)

Drug

2 Test ACE 500 mg tablets taken orally one time

Commercial ACE (1000 mg)

Drug

2 ACE 500 mg caplets taken orally one time

Commercial Ibuprofen (IBU) (400 mg)

Drug

2 IBU 200 mg soft-gels taken orally one time

Placebo

Drug

2 placebo caplets for acetaminophen taken orally one time

Primary outcomes

  1. Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)

    Time frame: 6 Hours

    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

Secondary outcomes

  1. Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)

    Time frame: 4 Hours

    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

  2. Time to meaningful pain relief

    Time frame: Within 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.

  3. Time to first perceptible pain relief

    Time frame: Within 6 Hours

    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.

  4. Time to confirmed first perceptible relief

    Time frame: Within 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.

  5. Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)

    Time frame: 4 hours

    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

  6. Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)

    Time frame: 6 hours

    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

  7. Duration of relief after dosing (time to rescue analgesic)

    Time frame: 6 Hours

    Minutes until rescue medication is given

  8. Proportion of subjects taking a rescue analgesic by 6 hours

    Time frame: 6 Hours

    Percentage of subjects using rescue medication through six hours

  9. Subject Global Evaluation assessed at hour 6 or at time of rescue

    Time frame: 6 hours

    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

  10. Pain relief (PAR) scores at 0.25 Hours

    Time frame: 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

  11. Pain relief (PAR) scores at 0.5 Hours

    Time frame: 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

  12. Pain relief (PAR) scores at 0.75 Hours

    Time frame: 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

  13. Pain relief (PAR) scores at 1 Hours

    Time frame: 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

  14. Pain relief (PAR) scores at 1.25 Hours

    Time frame: 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

  15. Pain relief (PAR) scores at 1.5 Hours

    Time frame: 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

  16. Pain relief (PAR) scores at 2 Hours

    Time frame: 2 hoursH

    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

  17. Pain relief (PAR) scores at 3 Hours

    Time frame: 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

  18. Pain relief (PAR) scores at 4 Hours

    Time frame: 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

  19. Pain relief (PAR) scores at 5 Hours

    Time frame: 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

  20. Pain relief (PAR) scores at 6 Hours

    Time frame: 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

  21. Pain intensity difference (PID) at 0.25 Hours

    Time frame: 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

  22. Pain intensity difference (PID) at 0.5 Hours

    Time frame: 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

  23. Pain intensity difference (PID) at 0.75 Hours

    Time frame: 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

  24. Pain intensity difference (PID) at 1 Hours

    Time frame: 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

  25. Pain intensity difference (PID) at 1.25 Hours

    Time frame: 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

  26. Pain intensity difference (PID) at 1.5 Hours

    Time frame: 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

  27. Pain intensity difference (PID) at 2 Hours

    Time frame: 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

  28. Pain intensity difference (PID) at 3 Hours

    Time frame: 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

  29. Pain intensity difference (PID) at 4 Hours

    Time frame: 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

  30. Pain intensity difference (PID) at 5 Hours

    Time frame: 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

  31. Pain intensity difference (PID) at 6 Hours

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

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 Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2014
Registry last updated
Dec 3, 2021

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.

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