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Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

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: NCT03879408
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

Tracking Information
First Submitted Date  ICMJE March 1, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE May 28, 2019
Actual Primary Completion Date November 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Time weighted 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 time point, as well as time of rescue (if applicable) before administration and at time of meaningful relief (if applicable).
  • Time weighted 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 time point, as well as time of rescue (if applicable) before administration and at time of meaningful relief (if applicable).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Time weighted sum of 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 each time point, as well as time of rescue (if applicable) before administration, and at time of meaningful relief (if applicable).
  • Time weighted sum of 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 each time point, as well as time of rescue (if applicable) before administration, and at time of meaningful relief (if applicable).
  • Time weighted sum of 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 each time point, as well as time of rescue (if applicable) before administration, and at time of meaningful relief (if applicable).
  • Time weighted 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 time point, as well as time of rescue (if applicable) before administration and at time of meaningful relief (if applicable).
  • Pain relief (PAR) scores at individual time points [ Time Frame: 0 to 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 (0.25, 0.5, 0.75, 1, 1.25, 1.5, and hourly from 2 through 12 hours (± 5 minutes) post dose, as well as at the time of rescue (if applicable), and time of meaningful pain relief (if applicable).
  • Pain Intensity Difference (PID) scores at individual time points [ Time Frame: 0 to 12 hours ]
    Pain intensity difference (PID) Scores will be measured using a 0-10 Numerical Rating Scale (0 = no pain, 10 = complete relief) at individual timepoints (0.25, 0.5, 0.75, 1, 1.25, 1.5, and hourly from 2 through 12 hours (± 5 minutes) post dose, as well as at the time of rescue (if applicable), and time of meaningful pain relief (if applicable).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
  • Drug: Placebo tablet
    Single dose of four placebo tablets
Study Arms  ICMJE
  • 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
    Intervention: Drug: 440 mg naproxen sodium with 1000 mg acetaminophen
  • 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
    Intervention: Drug: 220 mg naproxen sodium with 650 mg acetaminophen
  • 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
    Intervention: Drug: 10 mg hydrocodone + 650 mg acetaminophen
  • 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
    Intervention: Drug: 440 mg naproxen sodium
  • Placebo Comparator: Placebo tablet
    Single dose of four placebo tablets
    Intervention: Drug: Placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2019)
290
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
288
Actual Study Completion Date  ICMJE November 13, 2019
Actual Primary Completion Date November 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03879408
Other Study ID Numbers  ICMJE CCSPAA001068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )
Study Sponsor  ICMJE Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todd Bertoch, MD Jean Brown Research (JBR)
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP