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Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

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ClinicalTrials.gov Identifier: NCT03224403
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Johnson & Johnson Consumer and Personal Products Worldwide
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

Brief Summary:
To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Condition or disease Intervention/treatment Phase
Post-operative Dental Pain Drug: Test acetaminophen Drug: Commercial acetaminophen Drug: Commercial ibuprofen Drug: Placebo Phase 3

Detailed Description:
This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy and Safety Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test acetaminophen
Test acetaminophen 1000 mg dose
Drug: Test acetaminophen
single dose of 2 Test acetaminophen 500 mg tablets
Other Name: Test ACM

Active Comparator: Commercial acetaminophen
Commercial acetaminophen 1000 mg dose
Drug: Commercial acetaminophen
single dose of 2 acetaminophen 500 mg caplets
Other Name: Commercial ACM

Active Comparator: Commercial ibuprofen
Commercial ibuprofen, 400 mg dose
Drug: Commercial ibuprofen
Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules
Other Name: Commercial IBU

Placebo Comparator: Placebo
Placebo
Drug: Placebo
2 placebo caplets




Primary Outcome Measures :
  1. Time to confirmed perceptible pain relief [ Time Frame: 0-4 hours ]
    Time in minutes from dosing to perceptible pain relief as indicated on the first stopwatch. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The time to perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.


Secondary Outcome Measures :
  1. Time to meaningful pain relief [ Time Frame: 0-4 hours ]
    Time in minutes until meaningful pain relief is 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.

  2. 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 ]
    Percentage of subjects with confirmed perceptible relief at 30 minutes, 29 minutes, 28 minutes, etc. A stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.



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Ages Eligible for Study:   17 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 17 to 50 years old
  2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
  3. Dental extraction of three or four third molars
  4. Meets post-surgical pain criteria
  5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

  1. Currently pregnant or planning to be pregnant or nursing a baby
  2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
  3. Inability to swallow whole large tablets or capsules
  4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
  5. Use of pain medications 5 or more times per week
  6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years
  7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
  8. Have a positive urine drug screen

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): NCT03224403


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
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Principal Investigator: Derek Muse Jean Brown Research/ BB Holdings

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Responsible Party: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
ClinicalTrials.gov Identifier: NCT03224403     History of Changes
Other Study ID Numbers: CO-170317095828-PACT
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: YODA

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action