<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/NCT03228992</url>
  </required_header>
  <id_info>
    <org_study_id>JBR-002</org_study_id>
    <nct_id>NCT03228992</nct_id>
  </id_info>
  <brief_title>Ibuprofen Versus Placebo For Muscle Soreness</brief_title>
  <official_title>A DOUBLE-BLIND, REPEAT-DOSE, PARALLEL GROUP, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jean Brown Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jean Brown Research</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>
      The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing&#xD;
      the safety and efficacy of oral ibuprofen to placebo over 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and&#xD;
      efficacy study. Healthy male or female subjects who have a history of occasional muscle&#xD;
      soreness and are not currently exercising will be asked to volunteer for the study. All&#xD;
      subjects will complete an informed consent process prior to study procedures.&#xD;
&#xD;
      The study duration is anticipated to be approximately 4 months. Each subject may be in the&#xD;
      study for up to 45 days including screening, run-in, inpatient and outpatient dosing and&#xD;
      assessments, follow-up visit and follow-up telephone contact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Model Sensitivity</measure>
    <time_frame>24 hours</time_frame>
    <description>Assess whether ibuprofen provides more relief than placebo in the DOMS model.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Muscle Soreness</condition>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen 400 mg</intervention_name>
    <description>Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.</description>
    <arm_group_label>Ibuprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive 4 doses of placebo over a 24 hour period.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects must meet the following criteria to be included in the study:&#xD;
&#xD;
          1. Male or female subjects aged 18-55 years;&#xD;
&#xD;
          2. In good general health;&#xD;
&#xD;
          3. Non-pregnant, non-lactating female subjects must be:&#xD;
&#xD;
               1. physically incapable of childbearing potential (postmenopausal for more than 1&#xD;
                  year or surgically sterile) or&#xD;
&#xD;
               2. practicing an acceptable method of contraception (hormonal, barrier with&#xD;
                  spermicide, intrauterine device, vasectomized or same sex partner, or&#xD;
                  abstinence). Subjects using hormonal birth control must have been on a stable&#xD;
                  dose of treatment for at least 30 days and received at least 1 cycle of treatment&#xD;
                  prior to randomization.&#xD;
&#xD;
          4. History of experiencing muscle pain/soreness after moderately strenuous exercise;&#xD;
&#xD;
        Subjects are excluded from the study if any of the following criteria apply:&#xD;
&#xD;
          1. Currently participating in an exercise regimen.&#xD;
&#xD;
          2. Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;&#xD;
&#xD;
          3. History of rhabdomyolysis;&#xD;
&#xD;
          4. Have participated in an investigational study within the past 30 days of screening;&#xD;
&#xD;
          5. Are an employee or relative of an employee of the study site (directly involved with&#xD;
             the study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://jeanbrownresearch.com</url>
    <description>Company Website</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>May 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jean Brown Research</investigator_affiliation>
    <investigator_full_name>Derek Muse</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03228992
org study id: JBR-002
nct id: NCT03228992
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing
      the safety and efficacy of oral ibuprofen to placebo over 24 hours.
This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and
      efficacy study. Healthy male or female subjects who have a history of occasional muscle
      soreness and are not currently exercising will be asked to volunteer for the study. All
      subjects will complete an informed consent process prior to study procedures.

      The study duration is anticipated to be approximately 4 months. Each subject may be in the
      study for up to 45 days including screening, run-in, inpatient and outpatient dosing and
      assessments, follow-up visit and follow-up telephone contact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Model Sensitivity
time frame: 24 hours
description: Assess whether ibuprofen provides more relief than placebo in the DOMS model.
arm group label: Ibuprofen
arm group type: Active Comparator
description: Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
intervention type: Drug
intervention name: Ibuprofen 400 mg
description: Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.
arm group label: Ibuprofen
intervention type: Other
intervention name: Placebo
description: Subjects will receive 4 doses of placebo over a 24 hour period.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://jeanbrownresearch.com
description: Company Website
responsible party type: Principal Investigator
investigator affiliation: Jean Brown Research
investigator full name: Derek Muse
investigator title: Principal Investigator
mesh term: Myalgia
mesh term: Ibuprofen
sharing ipd: No