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Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

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ClinicalTrials.gov Identifier: NCT03879408
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

Brief Summary:
Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Condition or disease Intervention/treatment Phase
Pain Drug: 440 mg naproxen sodium with 1000 mg acetaminophen Drug: 220 mg naproxen sodium with 650 mg acetaminophen Drug: 10 mg hydrocodone + 650 mg acetaminophen Drug: 440 mg naproxen sodium Drug: Placebo tablet Phase 2

Detailed Description:
This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 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: Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : October 11, 2019
Estimated Study Completion Date : October 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 440 mg naproxen sodium with 1000 mg acetaminophen
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
Drug: 440 mg naproxen sodium with 1000 mg acetaminophen
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
Other Name: Naproxen Sodium with Acetaminophen - High Dose

Experimental: 220 mg naproxen sodium with 650 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
Drug: 220 mg naproxen sodium with 650 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
Other Name: Naproxen Sodium with Acetaminophen - Low Dose

Active Comparator: 10 mg hydrocodone + 650 mg acetaminophen
10 mg hydrocodone + 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
Drug: 10 mg hydrocodone + 650 mg acetaminophen
10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
Other Name: Commercial Hydrocodone + Acetaminophen Tablet

Active Comparator: 440 mg naproxen sodium
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
Drug: 440 mg naproxen sodium
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
Other Name: Naproxen sodium

Placebo Comparator: Placebo tablet
Single dose of four placebo tablets
Drug: Placebo tablet
Single dose of four placebo tablets




Primary Outcome Measures :
  1. Time Weighted Sum of Pain Intensity Difference from 0 to 6 hours (SPID 6) [ Time Frame: 0 to 6 hours ]
    Time-weighted sum of the pain intensity difference scores (SPID) will be measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) and will be collected at baseline, at each scheduled time point, at time of rescue (if applicable), and at time of perceptible and meaningful pain relief (if applicable).

  2. Time Weighted Sum of Pain Intensity Difference from 0 to 12 hours (SPID 12) [ Time Frame: 0 to 12 hours ]
    Time-weighted sum of the pain intensity difference scores (SPID) will be measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) and will be collected at baseline, at each scheduled time point, at time of rescue (if applicable), and at time of perceptible and meaningful pain relief (if applicable).


Secondary Outcome Measures :
  1. Time Weighted Total Pain Relief from 0 to 6 hours (TOTPAR 6) [ Time Frame: 0 to 6 hours ]
    Time-weighted total pain relief (TOTPAR) will be measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief) and will be collected at baseline, at each scheduled time point, at time of rescue (if applicable), and at time of perceptible and meaningful pain relief (if applicable).

  2. Time Weighted Total Pain Relief from 0 to 8 hours (TOTPAR 8) [ Time Frame: 0 to 8 hours ]
    Time-weighted total pain relief (TOTPAR) will be measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief) and will be collected at baseline, at each scheduled time point, at time of rescue (if applicable), and at time of perceptible and meaningful pain relief (if applicable).

  3. Time Weighted Total Pain Relief from 0 to 12 hours (TOTPAR 12) [ Time Frame: 0 to 12 hours ]
    Time-weighted total pain relief (TOTPAR) will be measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief) and will be collected at baseline, at each scheduled time point, at time of rescue (if applicable), and at time of perceptible and meaningful pain relief (if applicable).

  4. Time Weighted Sum of Pain Intensity Difference from 0 to 8 hours (SPID 8) [ Time Frame: 0 to 8 hours ]
    Time-weighted sum of the pain intensity difference scores (SPID) will be measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) and will be collected at baseline, at each scheduled time point, at time of rescue (if applicable), and at time of perceptible and meaningful pain relief (if applicable).

  5. Pain Relief (PAR) scores at 0.25 hours [ Time Frame: 0.25 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  6. Pain Relief (PAR) scores at 0.5 hours [ Time Frame: 0.5 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  7. Pain Relief (PAR) scores at 0.75 hours [ Time Frame: 0.75 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  8. Pain Relief (PAR) scores at 1 hour [ Time Frame: 1 hour ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  9. Pain Relief (PAR) scores at 1.25 hours [ Time Frame: 1.25 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  10. Pain Relief (PAR) scores at 1.5 hours [ Time Frame: 1.5 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  11. Pain Relief (PAR) scores at 2 hours [ Time Frame: 2 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  12. Pain relief (PAR) scores at 3 hours [ Time Frame: 3 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  13. Pain Relief (PAR) scores at 4 hours [ Time Frame: 4 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  14. Pain Relief (PAR) scores at 5 hours [ Time Frame: 5 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  15. Pain Relief (PAR) scores at 6 hours [ Time Frame: 6 hours ]
    Pain Relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  16. Pain Relief (PAR) scores at 7 hours [ Time Frame: 7 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  17. Pain Relief (PAR) scores at 8 hours [ Time Frame: 8 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  18. Pain Relief (PAR) scores at 9 hours [ Time Frame: 9 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  19. Pain Relief (PAR) scores at 10 hours [ Time Frame: 10 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  20. Pain Relief (PAR) scores at 11 hours [ Time Frame: 11 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  21. Pain Relief (PAR) scores at 12 hours [ Time Frame: 12 hours ]
    Pain relief (PAR) scores will be measured using a 0-10 Numerical Rating Scale (0 = no relief, 10 = complete relief) at individual time points.

  22. Pain Intensity Difference (PID) scores at 0.25 hours [ Time Frame: 0.25 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  23. Pain Intensity Difference (PID) scores at 0.5 hours [ Time Frame: 0.5 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  24. Pain Intensity Difference (PID) scores at 0.75 hours [ Time Frame: 0.75 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  25. Pain Intensity Difference (PID) scores at 1 hour [ Time Frame: 1 hour ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  26. Pain Intensity Difference (PID) scores at 1.25 hours [ Time Frame: 1.25 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  27. Pain Intensity Difference (PID) scores at 1.5 hours [ Time Frame: 1.5 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  28. Pain Intensity Difference (PID) scores at 2 hours [ Time Frame: 2 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  29. Pain Intensity Difference (PID) scores at 3 hours [ Time Frame: 3 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  30. Pain Intensity Difference (PID) scores at 4 hours [ Time Frame: 4 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  31. Pain Intensity Difference (PID) scores at 5 hours [ Time Frame: 5 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  32. Pain Intensity Difference (PID) scores at 6 hours [ Time Frame: 6 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  33. Pain Intensity Difference (PID) scores at 7 hours [ Time Frame: 7 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  34. Pain Intensity Difference (PID) scores at 8 hours [ Time Frame: 8 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  35. Pain Intensity Difference (PID) scores at 9 hours [ Time Frame: 9 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  36. Pain Intensity Difference (PID) scores at 10 hours [ Time Frame: 10 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  37. Pain Intensity Difference (PID) scores at 11 hours [ Time Frame: 11 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  38. Pain Intensity Difference (PID) scores at 12 hours [ Time Frame: 12 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = very severe pain) at individual time points.

  39. Subject Global Evaluation at 12 hours or rescue, whichever occurs first [ Time Frame: 12 hours or time of rescue medication, whichever occurs first ]
    Self-reported pain relief. Subject global evaluation of the investigational product will be collected at hour 12, at the time of rescue medication, or at the time of subject withdrawal with a 0-4 rating scale: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Males of females 17-50 years old
  2. Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
  3. Surgical removal of up to four third molars, of which, two must be mandibular impactions
  4. Meets requirements for post -surgical pain level
  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 become pregnant or male with pregnant partner or partner currently trying to become pregnant
  2. Have known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, 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 peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding

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): NCT03879408


Contacts
Layout table for location contacts
Contact: Danielle Brown, PhD, MS 215 273-7342 ext 7342 dbrown37@its.jnj.com
Contact: Steven Sacavage, PharmD, MS 215 273-8568 ext 8568 SSacavag@its.jnj.com

Locations
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United States, Utah
Jean Brown Research Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Todd Bertoch, MD    801-261-2000    tbertoch@jbrutah.com   
Sponsors and Collaborators
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Investigators
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Principal Investigator: Todd Bertoch, MD Jean Brown Research (JBR)

Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
ClinicalTrials.gov Identifier: NCT03879408     History of Changes
Other Study ID Numbers: CCSPAA001068
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
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
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ):
Analgesics
Dental Pain
Naproxen
Acetaminophen
Pain
Additional relevant MeSH terms:
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Acetaminophen
Naproxen
Hydrocodone
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
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents