An interventional study of Metaqil™ Oral Rinse and Placebo in Medication Associated Metallic Taste , Dysgeusia, sponsored by You First Services. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by You First Services · Not applicable, Interventional, and Supportive care
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.
52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.
This study's enrollment of 52 is close to the median of 49 across 28 interventional studies indexed under Dysgeusia.
Browse Dysgeusia studies →You First Services is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This arm will use a placebo with out the active ingredients same way the experimental arm do.
Device: Placebo
Metaqil™ is a proprietary formulation of GRAS ingradients
Placebo formulation with out the active ingredients
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..
Time frame: 4 weeks
Safety evaluation of the test Oral Rinse
Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.
Time frame: 4 Weeks
Ran from May 2017 to primary completion in Sep 2018, 15 months.
Of 18 interventional studies with no phase under Dysgeusia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 16. This study's 15 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
You First Services