<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447040</url>
  </required_header>
  <id_info>
    <org_study_id>CCSPAA002398</org_study_id>
    <nct_id>NCT04447040</nct_id>
  </id_info>
  <brief_title>Acetaminophen/Naproxen Sodium Dose Ranging Study</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer Inc., McNeil Consumer Healthcare Division</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study assessing the relative efficacy of five strengths of a fixed combination of&#xD;
      acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s)&#xD;
      for further development and to evaluate the safety of a fixed combination of naproxen sodium&#xD;
      and acetaminophen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic&#xD;
      efficacy and safety profile of the following doses of a fixed combination of Acetaminophen&#xD;
      (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen&#xD;
      Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C,&#xD;
      Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo]&#xD;
      following surgical extraction of four third molars.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Actual">May 3, 2021</completion_date>
  <primary_completion_date type="Actual">April 9, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Post-operative dental pain following third molar extraction.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time Weighted Sum of Pain Intensity Difference from 0 to 12 hours after dosing (SPID 0-12)</measure>
    <time_frame>0 to 12 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time Weighted Sum of Pain Relief from 0 to 12 hours (TOTPAR 0-12)</measure>
    <time_frame>0 to 12 hours</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time weighted sum of pain intensity difference from 6 to 12 hours (SPID 6-12)</measure>
    <time_frame>6 to 12 hours</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first use of rescue analgesic</measure>
    <time_frame>0 to 24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">304</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Acetaminophen/naproxen sodium Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetaminophen/naproxen sodium Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetaminophen/naproxen sodium Dose C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetaminophen/naproxen sodium Dose D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetaminophen/naproxen sodium Dose E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets administered as a single two-tablet dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen/naproxen sodium Dose A</intervention_name>
    <description>Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.</description>
    <arm_group_label>Acetaminophen/naproxen sodium Dose A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen/naproxen sodium Dose B</intervention_name>
    <description>Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.</description>
    <arm_group_label>Acetaminophen/naproxen sodium Dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen/naproxen sodium Dose C</intervention_name>
    <description>Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.</description>
    <arm_group_label>Acetaminophen/naproxen sodium Dose C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen/naproxen sodium Dose D</intervention_name>
    <description>Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.</description>
    <arm_group_label>Acetaminophen/naproxen sodium Dose D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen/naproxen sodium Dose E</intervention_name>
    <description>Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.</description>
    <arm_group_label>Acetaminophen/naproxen sodium Dose E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets administered as a single two-tablet dose.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females 17-50 years old&#xD;
&#xD;
          2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive)&#xD;
             at screening&#xD;
&#xD;
          3. Surgical removal of three or four third molars, of which, two must be mandibular&#xD;
             impactions&#xD;
&#xD;
          4. Meets requirements for post-surgical pain level&#xD;
&#xD;
          5. Females of childbearing potential and males agree to contraceptive requirements of&#xD;
             study&#xD;
&#xD;
          6. Have a negative urine drug screen at screening, and on day of surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant&#xD;
             partner or partner currently trying to become pregnant&#xD;
&#xD;
          2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including&#xD;
             aspirin, or to acetaminophen, oxycodone or other opioids;&#xD;
&#xD;
          3. Not able to swallow whole large tablets or capsules&#xD;
&#xD;
          4. History of any condition (s) in investigator's opinion, may jeopardize subject safety,&#xD;
             well-being and integrity of study&#xD;
&#xD;
          5. Use analgesics 5 or more times per week&#xD;
&#xD;
          6. History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by&#xD;
             the investigator site staff, in the last 5 years&#xD;
&#xD;
          7. Use of any immunosuppressive drugs within 2 weeks of screening&#xD;
&#xD;
          8. History of endoscopically documented peptic ulcer disease or bleeding disorder in the&#xD;
             last 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Bertoch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>JBR Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>JBR Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <disposition_first_submitted>April 6, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>April 6, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 8, 2022</disposition_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Analgesics</keyword>
  <keyword>Dental Pain</keyword>
  <keyword>Acetaminophen</keyword>
  <keyword>Naproxen Sodium</keyword>
  <keyword>Pain</keyword>
  <keyword>Fixed-Dose</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Naproxen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Johnson &amp; 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.</ipd_description>
    <ipd_url>http://yoda.yale.edu.</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447040
org study id: CCSPAA002398
nct id: NCT04447040
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Post-operative dental pain following third molar extraction.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time Weighted Sum of Pain Intensity Difference from 0 to 12 hours after dosing (SPID 0-12)
time frame: 0 to 12 hours
description: 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.
measure: Time Weighted Sum of Pain Relief from 0 to 12 hours (TOTPAR 0-12)
time frame: 0 to 12 hours
description: 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.
measure: Time weighted sum of pain intensity difference from 6 to 12 hours (SPID 6-12)
time frame: 6 to 12 hours
description: 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.
measure: Time to first use of rescue analgesic
time frame: 0 to 24 hours
arm group label: Acetaminophen/naproxen sodium Dose A
arm group type: Experimental
description: Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose B
arm group type: Experimental
description: Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose C
arm group type: Experimental
description: Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose D
arm group type: Experimental
description: Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose E
arm group type: Experimental
description: Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets administered as a single two-tablet dose.
intervention type: Drug
intervention name: Acetaminophen/naproxen sodium Dose A
description: Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose A
intervention type: Drug
intervention name: Acetaminophen/naproxen sodium Dose B
description: Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose B
intervention type: Drug
intervention name: Acetaminophen/naproxen sodium Dose C
description: Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose C
intervention type: Drug
intervention name: Acetaminophen/naproxen sodium Dose D
description: Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose D
intervention type: Drug
intervention name: Acetaminophen/naproxen sodium Dose E
description: Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
arm group label: Acetaminophen/naproxen sodium Dose E
intervention type: Drug
intervention name: Placebo
description: Placebo tablets administered as a single two-tablet dose.
arm group label: Placebo
criteria: 
gender: All
minimum age: 17 Years
maximum age: 50 Years
healthy volunteers: No
last name: Todd Bertoch, MD
role: Principal Investigator
affiliation: JBR Clinical Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acetaminophen
mesh term: Naproxen
sharing ipd: Yes
ipd 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.
ipd url: http://yoda.yale.edu.