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Completed

NCT Number: NCT01960114

Study of Long-Acting Acetaminophen in Postoperative Dental Pain

The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

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Key information

Conditions

Dental Pain Facial Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

17 year–45 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

  • Must be at least 17 and less than 46 years of age
  • Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
  • Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
  • Experiencing moderate to severe pain after extraction of third molars.

Exclusion criteria

  • Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
  • Cannot be pregnant (or planning to be pregnant) or nursing a baby
  • Unable to swallow whole large tablets or caplets.
  • Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.

Treatment and study plan

Acetaminophen ER

Drug

Single dose (2 tablets) Acetaminophen ER 750 mg

Placebo

Drug

Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Primary outcomes

  1. Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)

    Time frame: 10 Hours

    Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.

Secondary outcomes

  1. Time to Confirmed First Perceptible Pain Relief

    Time frame: Within 12 Hours

    Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.

  2. Time to Meaningful Pain Relief

    Time frame: Within 12 Hours

    Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.

  3. Duration of Pain Relief

    Time frame: Within 12 Hours

    Minutes until rescue medication was given.

  4. Patient Global Evaluation

    Time frame: 12 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.

Sponsors and collaborators

Lead sponsor

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Industry

Registry information

Official study title

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Jul 10, 2015

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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