<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/NCT01681667</url>
  </required_header>
  <id_info>
    <org_study_id>3003</org_study_id>
    <nct_id>NCT01681667</nct_id>
  </id_info>
  <brief_title>Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain</brief_title>
  <official_title>Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albany Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is&#xD;
      also known that ibuprofen levels in the blood rise higher and faster if the medication is&#xD;
      taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a&#xD;
      liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also&#xD;
      determine whether patients with sore throat prefer to take pill or liquid form of the&#xD;
      medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is a common emergency and urgent care complaint. Ibuprofen is known to be an effective&#xD;
      treatment for many forms of pain. Sore throat has been established to be an acceptable model&#xD;
      of analgesic effect, and ibuprofen has been found to offer relief in studies of sore throat.&#xD;
      Several studies have demonstrated that ibuprofen in suspension is absorbed into the system&#xD;
      more quickly and results in earlier maximum blood concentrations. To date, no study has&#xD;
      evaluated onset to analgesia as reported by the patient for suspension versus tablet&#xD;
      formation of ibuprofen in an emergency department population presenting with complaints of&#xD;
      sore throat. This is a double blinded randomized placebo controlled trial to compare&#xD;
      suspension versus tablet ibuprofen in an emergency department population presenting with sore&#xD;
      throat. The purpose of this study is to assess whether ibuprofen in suspension form results&#xD;
      in relief of pain more quickly than the tablet form of an equivalent dose of ibuprofen. We&#xD;
      will also determine if there is an interval difference from time of analgesia administration&#xD;
      to perception of analgesia that is clinically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of pain relief</measure>
    <time_frame>1 hour</time_frame>
    <description>Comparing liquid ibuprofen to tablet ibuprofen to determine which works faster to relieve sore throat pain. We will also determine whether patients with sore throat prefer to take pill or liquid form of medication.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pharyngitis</condition>
  <arm_group>
    <arm_group_label>ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>liquid ibuprofen 400mg compared to tablet ibuprofen 400mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sugar pill or liquid</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>ibuprofen liquid 400mg vs. ibuprofen tablet 400mg</description>
    <arm_group_label>ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 12 years and less than 65 years&#xD;
&#xD;
          -  Weight &gt; 40 kg&#xD;
&#xD;
          -  a provider order for ibuprofen to address pharyngitis pain.&#xD;
&#xD;
          -  Initial Numeric Pain Score &gt; 6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy or hypersensitivity to aspirin or NSAIDs&#xD;
&#xD;
          -  Inability to swallow pills&#xD;
&#xD;
          -  Inability to carry out informed consent in English&#xD;
&#xD;
          -  Inability to complete a visual analog pain scale&#xD;
&#xD;
          -  A concomitant order for another class of analgesic&#xD;
&#xD;
          -  Use of analgesic within 8 hours&#xD;
&#xD;
          -  Known 3rd trimester pregnancy&#xD;
&#xD;
          -  Significant medical conditions where participation would pose an unnecessary barrier&#xD;
             to ongoing care.&#xD;
&#xD;
          -  Those taking opioid medications for more than 3 days&#xD;
&#xD;
          -  Weight &lt; 40 kg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne R Triner, DO, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albany Medical College Department of Emergency Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nancy Robak, RN, MPH</last_name>
    <phone>518-262-3773</phone>
    <email>RobakN@mail.amc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Albany Medical Center Emergency Department</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Wayne Triner, DO, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>March 10, 2014</last_update_submitted>
  <last_update_submitted_qc>March 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albany Medical College</investigator_affiliation>
    <investigator_full_name>Wayne Triner</investigator_full_name>
    <investigator_title>Professor and Research Director Dept.of Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01681667
org study id: 3003
nct id: NCT01681667
lead sponsor: 
has dmc: Yes
Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is
      also known that ibuprofen levels in the blood rise higher and faster if the medication is
      taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a
      liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also
      determine whether patients with sore throat prefer to take pill or liquid form of the
      medication.
Pain is a common emergency and urgent care complaint. Ibuprofen is known to be an effective
      treatment for many forms of pain. Sore throat has been established to be an acceptable model
      of analgesic effect, and ibuprofen has been found to offer relief in studies of sore throat.
      Several studies have demonstrated that ibuprofen in suspension is absorbed into the system
      more quickly and results in earlier maximum blood concentrations. To date, no study has
      evaluated onset to analgesia as reported by the patient for suspension versus tablet
      formation of ibuprofen in an emergency department population presenting with complaints of
      sore throat. This is a double blinded randomized placebo controlled trial to compare
      suspension versus tablet ibuprofen in an emergency department population presenting with sore
      throat. The purpose of this study is to assess whether ibuprofen in suspension form results
      in relief of pain more quickly than the tablet form of an equivalent dose of ibuprofen. We
      will also determine if there is an interval difference from time of analgesia administration
      to perception of analgesia that is clinically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Time of pain relief
time frame: 1 hour
description: Comparing liquid ibuprofen to tablet ibuprofen to determine which works faster to relieve sore throat pain. We will also determine whether patients with sore throat prefer to take pill or liquid form of medication.
arm group label: ibuprofen
arm group type: Active Comparator
description: liquid ibuprofen 400mg compared to tablet ibuprofen 400mg
arm group label: sugar pill or liquid
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Ibuprofen
description: ibuprofen liquid 400mg vs. ibuprofen tablet 400mg
arm group label: ibuprofen
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wayne R Triner, DO, MPH
role: Principal Investigator
affiliation: Albany Medical College Department of Emergency Medicine
last name: Nancy Robak, RN, MPH
phone: 518-262-3773
email: RobakN@mail.amc.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albany Medical College
investigator full name: Wayne Triner
investigator title: Professor and Research Director Dept.of Emergency Medicine
mesh term: Pharyngitis
mesh term: Ibuprofen