MEDTASTE: Sensory Evaluation of the Taste of Pediatric Medicines

Sponsor

Monell Chemical Senses Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03627351

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), Children's Hospital of Philadelphia (Other)

200

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy

Detailed Description

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

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Taste of Medicines for Children: Genetic Variation and Medical Adherence (Aim 1)

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Jul 16, 2021

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Healthy Women and Men Group of healthy women and men

Outcome Measures

Primary Outcome Measures

Flavor ratings (using general labelled magnitude scale, gLMS) of pediatric medicines and excipients [Through study completion, an average of 3 years]
Flavor ratings of each pediatric medicine and excipient as assessed by the general labelled magnitude scale [gLMS]; each medicine and each excipient is rated individually; range 0 [minimum, no flavor] to 100 [maximum; strongest flavor rating]
Palatability ratings (using hedonic general labelled magnitude scale, hedonic gLMS) of the flavor of pediatric medicines and excipients [Through study completion, an average of 3 years]
Ratings of the palatabillity of the flavor of each medicine and excipient, as assessed by the hedonic general labelled magnitude scale; each medicine and each excipient is rated individually, range: -100 [minimum palatability rating] to 0 [neither like nor dislike] to 100 [maximum /strongest imaginable palatability ratings]
Detect genetic associations (GWAS) with flavor and palatability ratings of pediatric medicines [After study completion, 2021-2022]
To detect genetic associations with taste and palatability ratings phenotypes of each medicine

Secondary Outcome Measures

Hedonic ratings (using 5 face scale) of the flavor of pediatric medicines [Through study completion, an average of 3 years]
Ratings of the liking of the flavor of each medicine, as assessed by the simpler, hedonic 5-face scale; each medicine is rated individually; range: 1 (minimum, greatest dislike score) to 5 (maximum; greatest liking score). Each panelist's hedonic 5-face scale rating will be correlated with the more sophisticated hedonic gLMS rating for each medicine to lay the foundation for future research in pediatric populations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria include the following:

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 had current (within the last 24 hours) use of sildenafil (Viagra), tadalafil (Cialis), and verdenafil (Levitra) are also exclusion criteria. These drugs can be used as needed for erectile dysfunction. They are also used as a daily treatment for pulmonary arterial hypertension. With CYP450 3A4 blockade and current use, hypotension, syncope, and prolonged erection are possible.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monell Chemical Senses Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Monell Chemical Senses Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Children's Hospital of Philadelphia

Investigators

Principal Investigator: Julie A. Mennella, PhD, Monell Chemical Senses Center
Principal Investigator: Elizabeth Lowenthal, MD, Children's Hospital of Philadelphia