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Study of Long-Acting Acetaminophen in Postoperative Dental Pain

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ClinicalTrials.gov Identifier: NCT01960114
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : June 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Pain Drug: Acetaminophen ER Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960114


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Investigators
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Study Director: McNeil Study Director McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
More Information
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Responsible Party: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
ClinicalTrials.gov Identifier: NCT01960114    
Other Study ID Numbers: AERPAI2001
First Posted: October 10, 2013    Key Record Dates
Results First Posted: June 10, 2015
Last Update Posted: July 10, 2015
Last Verified: June 2015
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. ):
Acetaminophen
Paracetamol Analgesics
Analgesics
Non-Narcotic Pain
 Postoperative Pain
Antipyretics Dental Surgery
Third molar extraction
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Acetaminophen
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics