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Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste

Sponsor
You First Services (Industry)
Overall Status
Completed
CT.gov ID
NCT02992314
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
19.3
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Metaqil™ Oral Rinse
  • Device: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Actual Study Start Date :
May 22, 2017
Actual Primary Completion Date :
Sep 18, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metaqil™ Oral Rinse

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.

Device: Metaqil™ Oral Rinse
Metaqil™ is a proprietary formulation of GRAS ingradients
Placebo Comparator: Placebo Oral Rinse

This arm will use a placebo with out the active ingredients same way the experimental arm do.

Device: Placebo
Placebo formulation with out the active ingredients

Outcome Measures

Primary Outcome Measures

  1. Relief of medication associated metallic taste [4 weeks]

    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

  1. Safety evaluation of the test Oral Rinse [4 Weeks]

    Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.

  2. Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.

  3. Subject is between the ages of 18 and 75 years inclusive.

  4. Subject will not have professional cleaning during the 3-month trial.

  5. 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.

  6. Subject has a minimum of 16 natural teeth and a complaint of moderate to severe medication associated metallic taste.

  7. 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.

  8. Subject agrees to refrain from the use of other oral care products not supplied by the study center

  9. Subject agrees to be compliant with study procedures.

  10. 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:

  1. 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).

  2. Subject has disqualifying acute or chronic medical illness as judged by the Principal Investigator.

  3. Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that has been shown to cause gingival enlargement or affect the gingivae.

  4. 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.

  5. Subject is pregnant (based on pregnancy result) or lactating.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY Buffalo New York United States 14214

Sponsors and Collaborators

  • You First Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
You First Services
ClinicalTrials.gov Identifier:
NCT02992314
Other Study ID Numbers:
  • MQ-101-16
First Posted:
Dec 14, 2016
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Dysgeusia
Taste Disorders

Study Results

No Results Posted as of Jan 22, 2021