Back to resultsDetermination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Primary Purpose
Medication Associated Metallic Taste , Dysgeusia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metaqil™ Oral Rinse
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Medication Associated Metallic Taste , Dysgeusia
Eligibility Criteria
Inclusion Criteria:
- Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- Subject is between the ages of 18 and 75 years inclusive.
- Subject will not have professional cleaning during the 3-month trial.
- Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
- Subject has a minimum of 16 natural teeth and a complaint of moderate to severe medication associated metallic taste.
- Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Colgate® Cavity Protection Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
- Subject agrees to refrain from the use of other oral care products not supplied by the study center
- Subject agrees to be compliant with study procedures.
- Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.
Exclusion Criteria:
- Subject has a condition that requires prophylactic antibiotics for dental examinations and treatments (e.g., has a history of valvular heart disease or a recently placed prosthetic joint).
- Subject has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
- Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that has been shown to cause gingival enlargement or affect the gingivae.
- Subject has taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen) within one week prior to baseline examination. Subjects taking long-term aspirin (81 mg/day) may be included in the trial, but subjects taking a larger dose will be excluded. Subjects taking blood thinners such as Coumadin (warfarin), Lovenox, or Plavix will be excluded.
- Subject is pregnant (based on pregnancy result) or lactating.
Sites / Locations
- Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metaqil™ Oral Rinse
Placebo Oral Rinse
Arm 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.
This arm will use a placebo with out the active ingredients same way the experimental arm do.
Outcomes
Primary Outcome Measures
Relief of medication associated metallic taste
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..
Secondary Outcome Measures
Safety evaluation of the test Oral Rinse
Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02992314
Brief Title
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Official Title
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
You First Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Associated Metallic Taste , Dysgeusia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metaqil™ Oral Rinse
Arm Type
Experimental
Arm 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 Title
Placebo Oral Rinse
Arm Type
Placebo Comparator
Arm Description
This arm will use a placebo with out the active ingredients same way the experimental arm do.
Intervention Type
Device
Intervention Name(s)
Metaqil™ Oral Rinse
Intervention Description
Metaqil™ is a proprietary formulation of GRAS ingradients
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo formulation with out the active ingredients
Primary Outcome Measure Information:
Title
Relief of medication associated metallic taste
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..
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety evaluation of the test Oral Rinse
Description
Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
Subject is between the ages of 18 and 75 years inclusive.
Subject will not have professional cleaning during the 3-month trial.
Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
Subject has a minimum of 16 natural teeth and a complaint of moderate to severe medication associated metallic taste.
Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Colgate® Cavity Protection Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
Subject agrees to refrain from the use of other oral care products not supplied by the study center
Subject agrees to be compliant with study procedures.
Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.
Exclusion Criteria:
Subject has a condition that requires prophylactic antibiotics for dental examinations and treatments (e.g., has a history of valvular heart disease or a recently placed prosthetic joint).
Subject has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that has been shown to cause gingival enlargement or affect the gingivae.
Subject has taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen) within one week prior to baseline examination. Subjects taking long-term aspirin (81 mg/day) may be included in the trial, but subjects taking a larger dose will be excluded. Subjects taking blood thinners such as Coumadin (warfarin), Lovenox, or Plavix will be excluded.
Subject is pregnant (based on pregnancy result) or lactating.
Facility Information:
Facility Name
Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
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