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Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (Industry)
Overall Status
Completed
CT.gov ID
NCT03879408
Collaborator
(none)
290
Enrollment
1
Location
5
Arms
5.6
Actual Duration (Months)
52.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Post-operative dental pain following third molar extraction.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
Actual Primary Completion Date :
Nov 7, 2019
Actual Study Completion Date :
Nov 13, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Naproxen sodium

    		•
    Placebo Comparator: Placebo tablet

    Single dose of four placebo tablets

    Drug: Placebo tablet
    Single dose of four placebo tablets

    Outcome Measures

    Primary Outcome Measures

    1. Time Weighted Sum of Pain Intensity Difference from 0 to 6 hours (SPID 6) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jean Brown Research Clinical Research Salt Lake City Utah United States 84107

    Sponsors and Collaborators

    • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

    Investigators

    • Principal Investigator: Todd Bertoch, MD, Jean Brown Research (JBR)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
    ClinicalTrials.gov Identifier:
    NCT03879408
    Other Study ID Numbers:
    • CCSPAA001068
    First Posted:
    Mar 18, 2019
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
    Analgesics
    Dental Pain
    Naproxen
    Acetaminophen
    Pain
    Additional relevant MeSH terms:
    Acetaminophen
    Naproxen
    Acetaminophen, hydrocodone drug combination
    Hydrocodone

    Study Results

    No Results Posted as of Nov 23, 2020