Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 83 for:    Taste Disorders AND sense

Sensory Evaluation of the Taste of Pediatric Medicines (MEDTASTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03627351
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Monell Chemical Senses Center

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
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 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 360 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 : September 1, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy Women and Men
Group of healthy women and men



Primary Outcome Measures :
  1. Flavor ratings (using general labelled magnitude scale, gLMS) of pediatric medicines and excipients [ Time Frame: 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]

  2. Palatability ratings (using hedonic general labelled magnitude scale, hedonic gLMS) of the flavor of pediatric medicines and excipients [ Time Frame: 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]

  3. Detect genetic associations (GWAS) with flavor and palatability ratings of pediatric medicines [ Time Frame: After study completion, 2021-2022 ]
    To detect genetic associations with taste and palatability ratings phenotypes of each medicine


Secondary Outcome Measures :
  1. Hedonic ratings (using 5 face scale) of the flavor of pediatric medicines [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Identification of genetic polymorphisms in DNA from saliva samples collected at baseline that are associated with variation in flavor and palatability ratings of pediatric medicines through genome wide association study of adult panelists


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy men and women between the ages of 18 and 55 years
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627351


Contacts
Layout table for location contacts
Contact: Julie A. Mennella, PhD 2675194880 mennella@monell.org

Locations
Layout table for location information
United States, Pennsylvania
Monell Chemical Senses Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Julie A Mennella, PhD    267-519-4880    mennella@monell.org   
Contact: Sara Snell, MS    2675194888    ssnell@monell.org   
Sponsors and Collaborators
Monell Chemical Senses Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Children's Hospital of Philadelphia
Investigators
Layout table for investigator information
Principal Investigator: Julie A. Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Elizabeth Lowenthal, MD Children's Hospital of Philadelphia

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT03627351     History of Changes
Other Study ID Numbers: T24653
R01DC011287 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: dbGAP
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 2023 and for 1 year
Access Criteria: To be developed

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monell Chemical Senses Center:
Taste
Odor
Sensory Panel
Flavor
Genes
Pediatric Medicines