<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/NCT01734759</url>
  </required_header>
  <id_info>
    <org_study_id>12-005823</org_study_id>
    <nct_id>NCT01734759</nct_id>
  </id_info>
  <brief_title>Influence of Medication Taste on Pediatric Prescribers' Prescribing Habits</brief_title>
  <official_title>Influence of Medication Palatability on Prescribing Habits of Pediatric Prescribers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if a medication taste test influences the prescribing&#xD;
      habits of pediatric prescribers at Mayo Clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Taste scores on the visual analog scale</measure>
    <time_frame>Change from baseline in taste scores at 3 months</time_frame>
    <description>Medication taste scores on the visual analog scale before and after a medication tasting will be measured.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Taste Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Taste Test</intervention_name>
    <description>Before the taste test each participant will fill out an informed consent form and an enrollment survey. Each participant will receive 0.5 mL of each study medication in the taste test. During the taste test each medication in a class will be labeled with a color name so as to prevent any bias from preconceived taste perception. They will record their perception of the medications taste on a visual analog scale (VAS). An anaphlyaxis kit will be on hand in case of emergencies. Between samples participants will cleanse their palate with a saltine cracker and 30 mL of water. 5 different classes of medications will be tested.&#xD;
Medications to be sampled and the corresponding dose of the test dose are:&#xD;
Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg&#xD;
Penicillins: penicillin VK 12.5 mg, amoxicillin 12.5 mg&#xD;
Analgesic/antipyretics: acetaminophen 16 mg, ibuprofen 10 mg&#xD;
Steroids: prednisolone 1.5 mg, prednisone 0.5 mg&#xD;
H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg</description>
    <arm_group_label>Taste Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects possess prescriptive authority (e.g. MD, nurse practitioner, physician's&#xD;
             assistant, medication therapy management pharmacists)&#xD;
&#xD;
          -  subjects have prescribed at least one of the study medications from one of the&#xD;
             medication classes to pediatric patients at an outpatient clinic in the three months&#xD;
             preceding the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects do not prescribe any of the tested medications&#xD;
&#xD;
          -  subject has an allergy to all of the study medications&#xD;
&#xD;
          -  subject is pregnant or breastfeeding&#xD;
&#xD;
          -  subject has a medical condition that prevents them from being involved in the taste&#xD;
             test&#xD;
&#xD;
        Participants are advised to be within or accessible to the Rochester, MN area during study&#xD;
        recruitment and accessible afterwards via mail, email or fax.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard Lee, PharmD, RPh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ole J Olson, Pharm.D., BCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle J LoTurco, Pharm.D.</last_name>
    <role>Study Director</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>November 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>October 18, 2013</last_update_submitted>
  <last_update_submitted_qc>October 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Bernard Lee</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>medication palatability</keyword>
  <keyword>medication taste</keyword>
  <!-- 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/NCT01734759
org study id: 12-005823
nct id: NCT01734759
lead sponsor: 
has dmc: No
The purpose of this study is to see if a medication taste test influences the prescribing
      habits of pediatric prescribers at Mayo Clinic.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Taste scores on the visual analog scale
time frame: Change from baseline in taste scores at 3 months
description: Medication taste scores on the visual analog scale before and after a medication tasting will be measured.
arm group label: Taste Test
arm group type: Experimental
intervention type: Drug
intervention name: Taste Test
description: Before the taste test each participant will fill out an informed consent form and an enrollment survey. Each participant will receive 0.5 mL of each study medication in the taste test. During the taste test each medication in a class will be labeled with a color name so as to prevent any bias from preconceived taste perception. They will record their perception of the medications taste on a visual analog scale (VAS). An anaphlyaxis kit will be on hand in case of emergencies. Between samples participants will cleanse their palate with a saltine cracker and 30 mL of water. 5 different classes of medications will be tested.
Medications to be sampled and the corresponding dose of the test dose are:
Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg
Penicillins: penicillin VK 12.5 mg, amoxicillin 12.5 mg
Analgesic/antipyretics: acetaminophen 16 mg, ibuprofen 10 mg
Steroids: prednisolone 1.5 mg, prednisone 0.5 mg
H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg
arm group label: Taste Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bernard Lee, PharmD, RPh
role: Principal Investigator
affiliation: Mayo Clinic
last name: Ole J Olson, Pharm.D., BCPS
role: Principal Investigator
affiliation: Mayo Clinic
last name: Michelle J LoTurco, Pharm.D.
role: Study Director
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Bernard Lee
investigator title: Principle Investigator