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Acetaminophen/Naproxen Sodium Dose Ranging Study

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ClinicalTrials.gov Identifier: NCT04447040
Recruitment Status : Completed
First Posted : June 25, 2020
Last Update Posted : June 9, 2021
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 the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

Condition or disease Intervention/treatment Phase
Pain Drug: Acetaminophen/naproxen sodium Dose A Drug: Acetaminophen/naproxen sodium Dose B Drug: Acetaminophen/naproxen sodium Dose C Drug: Acetaminophen/naproxen sodium Dose D Drug: Acetaminophen/naproxen sodium Dose E Drug: Placebo Phase 2

Detailed Description:
This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of four third molars.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 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-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
Actual Study Start Date : November 9, 2020
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : May 3, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.

Experimental: Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.

Experimental: Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.

Experimental: Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.

Experimental: Acetaminophen/naproxen sodium Dose E
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose E
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.

Placebo Comparator: Placebo
Placebo tablets administered as a single two-tablet dose.
Drug: Placebo
Placebo tablets administered as a single two-tablet dose.




Primary Outcome Measures :
  1. Time Weighted Sum of Pain Intensity Difference from 0 to 12 hours after dosing (SPID 0-12) [ Time Frame: 0 to 12 hours ]
    Time-weighted sum of the pain intensity difference scores (SPID) will be calculated using values collected on the pain intensity Numerical Rating Scale ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.


Secondary Outcome Measures :
  1. Time Weighted Sum of Pain Relief from 0 to 12 hours (TOTPAR 0-12) [ Time Frame: 0 to 12 hours ]
    Time-weighted sum of the pain relief scores (TOTPAR) will be calculated using values collected on the pain relief Numerical Rating Scale ranging from 0-10 (0= no relief, 10= complete relief) collected at each scheduled timepoint within the specified timeframe.

  2. Time weighted sum of pain intensity difference from 6 to 12 hours (SPID 6-12) [ Time Frame: 6 to 12 hours ]
    Time-weighted sum of the pain intensity difference scores (SPID) will be calculated using values collected on the pain intensity Numerical Rating Scale ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

  3. Time to first use of rescue analgesic [ Time Frame: 0 to 24 hours ]


Information from the National Library of Medicine

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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 or females 17-50 years old
  2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
  3. Surgical removal of three or 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 a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
  3. Not able to swallow whole 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, or substance abuse, as judged by the investigator site staff, in the last 5 years
  7. Use of any immunosuppressive drugs within 2 weeks of screening
  8. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

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): NCT04447040


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 Bertoch, MD JBR Clinical Research
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Responsible Party: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
ClinicalTrials.gov Identifier: NCT04447040    
Other Study ID Numbers: CCSPAA002398
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
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
Acetaminophen
Naproxen Sodium
Pain
Fixed-Dose
Additional relevant MeSH terms:
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Acetaminophen
Naproxen
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