Medication Associated Metallic Taste , DysgeusiaNCT02992314
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
A study testing Metaqil™ Oral Rinse in people with Medication Associated Metallic Taste , Dysgeusia, run by You First Services at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Medication Associated Metallic Taste , Dysgeusia
- What is being tested?
- Metaqil™ Oral Rinse
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
Buffalo, New York, 14214
About this study
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.
- Being tested
- Metaqil™ Oral Rinse, Placebo
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metaqil™ Oral RinseDevice
Metaqil™ is a proprietary formulation of GRAS ingradients
PlaceboDevice
Placebo formulation with out the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Metaqil™ Oral Rinse | Experimental | 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. Receives: Device: Metaqil™ Oral Rinse |
| Placebo Oral Rinse | Placebo comparator | This arm will use a placebo with out the active ingredients same way the experimental arm do. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 4 weeks
Secondary outcomes (1)
Safety evaluation of the test Oral Rinse
Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start22 May 2017
- Primary completion18 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Associated Metallic Taste , DysgeusiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- You First Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992314
- Sponsor's protocol ID
- MQ-101-16
- Status last verified
- Jan 2021
- First submitted
- 30 Nov 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
- ClinicalTrials.gov ID
- NCT02992314
- Acronym / sponsor ID
- MQ-101-16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- You First ServicesIndustry (pharma, biotech, devices)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metaqil™ Oral Rinse | Experimental | Device: Metaqil™ Oral RinseIn 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. |
| Placebo Oral Rinse | Placebo comparator | Device: PlaceboThis arm will use a placebo with out the active ingredients same way the experimental arm do. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metaqil™ Oral RinseMetaqil™ is a proprietary formulation of GRAS ingradients | Device | Metaqil™ Oral Rinse |
| PlaceboPlacebo formulation with out the active ingredients | Device | Placebo Oral Rinse |
Primary outcome
Relief of medication associated metallic taste
Time frame: 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..
1 secondary outcome
Safety evaluation of the test Oral Rinse
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metaqil™ Oral Rinse in people with Medication Associated Metallic Taste , Dysgeusia, run by You First Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of medication associated metallic taste (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.