Sensory Evaluation of the Taste of Pediatric Medicines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2024-03-01

Brief Summary

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The investigators will conduct a systematic study of the sensory perception of a diverse set of commonly used pediatric liquid medications and excipients in tandem with an equally complete genetic analysis of the adult sensory panelists to investigate the relationship between genetic variation and individual differences in the perceived flavor (taste, smell, irritation) of pediatric medicines. The flavor of each medicine and excipient will be measured individually using both cognitively demanding methods unsuitable for young children and simpler measures validated for use by children. Salivary DNA samples will be collected to carry out genome wide association study (GWAS).

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Detailed Description

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This is a single-site, cross-sectional, repeated measures study of healthy adult panelists which will investigate individual differences in the taste of a diverse set of commonly used pediatric liquid medications (e.g., clindamycin, prednisone, dexamethasone, mercaptopurine, ibuprofen, lopinavir/ritonavir, propylthiouracil) and excipients (e.g., sucrose, citric acid, bitter agents, salt, menthol and other odors) in tandem with genetic analysis. Because the medication given to pediatric patients is the whole liquid formulation (API + excipients), the investigators' approach will be to have panelists taste (without swallowing) what patients taste. Using validated psychophysical tools such as the general labelled magnitude scale (gLMS), the hedonic gLMS, and the hedonic 5-face scale, adults panelists will rate the intensity of the basic tastes, overall intensity, irritation, or palatability (hedonics) of a variety of pediatric drugs (with and without noseclips), along with generally recognized as safe (GRAS) taste and odor stimuli commonly used in basic research and/or as excipients in many liquid formulations These data will establish whether the palatability and flavor of each medicine varies among adult panelists. From these data, the investigators will determine a) whether the dislike of one medicine by a panelist predicts their dislike of another medicine in the same class or medicines with the same excipients; b) whether variation in the flavor and palatability ratings of each medicine relates to variation in genetic polymorphisms, as determined from the GWAS; and c) whether the panelists' palatability ratings of each medicine, as assessed by the simpler hedonic 5-face scale, is significantly related to hedonic gLMS ratings.

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Women and Men

Group of healthy women and men

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Men and women who are between the ages of 18 and 55 years

Exclusion Criteria

* For all female participants, a urine pregnancy test will be done on each testing day. Only those with a negative pregnancy test will be allowed to participate in taste testing.
* Smokers will be excluded since it alters flavor perception.
* Potential subjects will be excluded if they are on drugs with potential serious adverse effects that are mediated through CYP450 3A4 since ritonavir is a potent inhibitor of CYP450 3A4 and could lead to elevated levels of the prohibited drugs if swallowed. The prohibited drugs include the following:
* Alfuzosin (Uroxatral; alpha-1-adrenoreceptor antagonist)
* Astemizole (Hismanal; antihistamine)
* Bepridil (Vascor; calcium channel blocker)
* Cerivastatin (Baycol; statin)
* Cisapride (Propulsid; GI motility agent)
* Dronedarone (multaq; anti-arrhythmic)
* Ergotamine (Cafergot, Ergot derivatives)
* Flecainide (Tabocor; anti-arrhythmic)
* Lovastatin (Altoprev; HMG-CoA Reductase Inhibitor)
* Lurasidone (Latuda; antipsychotic)
* Midazolam (Versed; sedative/hypnotic)
* Pimozide (Orap; antipsychotic)
* Ranolazine (Ranexa; anti-anginal)
* Simvastatin (Zocor; statin)
* Terfenadine (Seldane; antihistamine)
* Tinidazole (Tindamax; anti-parasitic)
* Trazodone (Desyrel; antidepressant/sedative)
* Triazolam (Halcion; sedative)
* Warfarin (Coumadin; blood thinner)
* Potential subjects will be excluded if they have known allergies or hypersensitivity reactions to lopinavir, ritonavir, clindamycin, prednisone, dexamethasone, ibuprofen, 6-mercaptopurine, propylthiouracil, or any of the excipients in the liquid formulations to be tested.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes