Study of Long-Acting Acetaminophen in Postoperative Dental Pain

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) 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.

Study Overview

• Status: Completed
• Conditions: Dental Pain
• Intervention / Treatment: Drug: Acetaminophen ER; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 2

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 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen ER	Drug: Acetaminophen ER; Single dose (2 tablets) Acetaminophen ER 750 mg
Placebo Comparator: Placebo; Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo	Drug: Placebo; Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)	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.	10 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Confirmed First Perceptible Pain Relief	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.	Within 12 Hours
Time to Meaningful Pain Relief	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.	Within 12 Hours
Duration of Pain Relief	Minutes until rescue medication was given.	Within 12 Hours
Patient Global Evaluation	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.	12 Hours

Collaborators and Investigators

• Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Investigators: Study Director: McNeil Study Director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: June 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Postoperative Pain; Acetaminophen; Analgesics; Third molar extraction; Paracetamol Analgesics; Non-Narcotic Pain; Antipyretics Dental Surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: AERPAI2001