<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/NCT02992314</url>
  </required_header>
  <id_info>
    <org_study_id>MQ-101-16</org_study_id>
    <nct_id>NCT02992314</nct_id>
  </id_info>
  <brief_title>Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste</brief_title>
  <official_title>Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>You First Services</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>You First Services</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients taking chemotherapeutic agents often do not comply well with their dosing regiment&#xD;
      since many of these medications cause a metallic taste in the mouth. The primary intent is to&#xD;
      determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth&#xD;
      associated with various chemotherapeutic agents. This clinical study a randomized,&#xD;
      double-blind, single-treatment, parallel design with a placebo as the control. The duration&#xD;
      of the trial will be 1 month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">September 18, 2018</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relief of medication associated metallic taste</measure>
    <time_frame>4 weeks</time_frame>
    <description>Have patient complete a VAS ( visual analogue scale) scoring of the degree of metallic taste in the mouth as well as a VAS scoring of the amount of relief of the metallic taste..</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation of the test Oral Rinse</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Medication Associated Metallic Taste , Dysgeusia</condition>
  <arm_group>
    <arm_group_label>Metaqil™ Oral Rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm the test article, Metaqil ™ oral rinse, a proprietary formulation of agents including Monk fruit extract, which can minimize the metallic taste in the mouth caused by the patient's medications.&#xD;
Subjects rinse twice a day with 10 mL of the oral rinse for 30 seconds for 30 days.&#xD;
They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Rinse</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm will use a placebo with out the active ingredients same way the experimental arm do.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Metaqil™ Oral Rinse</intervention_name>
    <description>Metaqil™ is a proprietary formulation of GRAS ingradients</description>
    <arm_group_label>Metaqil™ Oral Rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo formulation with out the active ingredients</description>
    <arm_group_label>Placebo Oral Rinse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has read, signed and received a copy of the Informed Consent and HIPAA&#xD;
             authorization prior to study initiation.&#xD;
&#xD;
          2. Subject is able to follow verbal and/or written instructions, perform oral hygiene&#xD;
             procedures and return to the test facility for specified study examinations.&#xD;
&#xD;
          3. Subject is between the ages of 18 and 75 years inclusive.&#xD;
&#xD;
          4. Subject will not have professional cleaning during the 3-month trial.&#xD;
&#xD;
          5. Subject has no history of allergy to personal care consumer products, or their&#xD;
             ingredients, relevant to any ingredient in the test drug, as determined by the&#xD;
             Principal Investigator.&#xD;
&#xD;
          6. Subject has a minimum of 16 natural teeth and a complaint of moderate to severe&#xD;
             medication associated metallic taste.&#xD;
&#xD;
          7. Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice&#xD;
             other than the Colgate® Cavity Protection Fluoride toothpaste and study rinse provided&#xD;
             on Visit 1 for the duration of the study.&#xD;
&#xD;
          8. Subject agrees to refrain from the use of other oral care products not supplied by the&#xD;
             study center&#xD;
&#xD;
          9. Subject agrees to be compliant with study procedures.&#xD;
&#xD;
         10. Females of childbearing potential agree to use an adequate method of birth control and&#xD;
             agree to pregnancy testing at the first and second visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a condition that requires prophylactic antibiotics for dental examinations&#xD;
             and treatments (e.g., has a history of valvular heart disease or a recently placed&#xD;
             prosthetic joint).&#xD;
&#xD;
          2. Subject has disqualifying acute or chronic medical illness as judged by the Principal&#xD;
             Investigator.&#xD;
&#xD;
          3. Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that&#xD;
             has been shown to cause gingival enlargement or affect the gingivae.&#xD;
&#xD;
          4. Subject has taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs&#xD;
             (e.g., aspirin, ibuprofen) within one week prior to baseline examination. Subjects&#xD;
             taking long-term aspirin (81 mg/day) may be included in the trial, but subjects taking&#xD;
             a larger dose will be excluded. Subjects taking blood thinners such as Coumadin&#xD;
             (warfarin), Lovenox, or Plavix will be excluded.&#xD;
&#xD;
          5. Subject is pregnant (based on pregnancy result) or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysgeusia</mesh_term>
    <mesh_term>Taste Disorders</mesh_term>
  </condition_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/NCT02992314
org study id: MQ-101-16
nct id: NCT02992314
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Patients taking chemotherapeutic agents often do not comply well with their dosing regiment
      since many of these medications cause a metallic taste in the mouth. The primary intent is to
      determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth
      associated with various chemotherapeutic agents. This clinical study a randomized,
      double-blind, single-treatment, parallel design with a placebo as the control. The duration
      of the trial will be 1 month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Relief of medication associated metallic taste
time frame: 4 weeks
description: Have patient complete a VAS ( visual analogue scale) scoring of the degree of metallic taste in the mouth as well as a VAS scoring of the amount of relief of the metallic taste..
measure: Safety evaluation of the test Oral Rinse
time frame: 4 Weeks
description: Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.
arm group label: Metaqil™ Oral Rinse
arm group type: Experimental
description: In this arm the test article, Metaqil ™ oral rinse, a proprietary formulation of agents including Monk fruit extract, which can minimize the metallic taste in the mouth caused by the patient's medications.
Subjects rinse twice a day with 10 mL of the oral rinse for 30 seconds for 30 days.
They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing.
arm group label: Placebo Oral Rinse
arm group type: Placebo Comparator
description: This arm will use a placebo with out the active ingredients same way the experimental arm do.
intervention type: Device
intervention name: Metaqil™ Oral Rinse
description: Metaqil™ is a proprietary formulation of GRAS ingradients
arm group label: Metaqil™ Oral Rinse
intervention type: Device
intervention name: Placebo
description: Placebo formulation with out the active ingredients
arm group label: Placebo Oral Rinse
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dysgeusia
mesh term: Taste Disorders