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Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566979
Recruitment Status : Completed
First Posted : June 25, 2018
Results First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

Study Description
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Brief Summary:
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Condition or disease Intervention/treatment Phase
Post-operative Dental Pain Drug: Test naproxen sodium tablet Drug: Commercial naproxen sodium tablet Drug: Commercial naproxen sodium liquid gels capsule Drug: Placebo tablet 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 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 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, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Test naproxen sodium tablet
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)
 Drug: Test naproxen sodium tablet
Single dose of 2 test naproxen sodium 220 mg tablets
Other Name: Test NPX tablet
Active Comparator: Commercial naproxen sodium tablet
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets
 Drug: Commercial naproxen sodium tablet
Single dose of 2 naproxen sodium 220 mg tablets
Other Name: Commercial NPX tablet
Active Comparator: Commercial naproxen sodium liquid gels capsule
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules
 Drug: Commercial naproxen sodium liquid gels capsule
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
Other Name: Commercial NPX liquid gels capsule
Placebo Comparator: Placebo tablet
Single dose of two Placebo tablets
 Drug: Placebo tablet
2 placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Time to Confirmed Perceptible Pain Relief [ Time Frame: 12 hours ]
    Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.


Secondary Outcome Measures :
  1. Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments [ Time Frame: Up to 45 minutes after dosing ]
    Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.


Eligibility Criteria
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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 - 50 years old
  2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
  3. Dental extraction of three or four third molars
  4. Meets post-surgical pain
  5. Females of childbearing potential and males agree to contraceptive requirements of study
  6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

  1. Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant
  2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
  3. Not able to swallow large tablets or capsules
  4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
  5. Use analgesics 5 or more times per week
  6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
  7. Use of immunosuppressive drugs within 2 weeks of screening
  8. History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
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): NCT03566979


Locations
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United States, Utah
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Investigators
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Principal Investigator: Todd M Bertoch, MD JBR Clinical Research
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ):
Study Protocol  [PDF] July 19, 2018
Statistical Analysis Plan  [PDF] April 3, 2019

More Information
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Responsible Party: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
ClinicalTrials.gov Identifier: NCT03566979    
Other Study ID Numbers: CCSPAA000457
First Posted: June 25, 2018    Key Record Dates
Results First Posted: April 9, 2020
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu.

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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
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action