NCT01841710

Brief Summary

This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

April 24, 2013

Last Update Submit

March 14, 2016

Conditions

Healthy

Keywords

Bitter TastePediatric Medications

Outcome Measures

Primary Outcomes (1)

  • Psychophysical data for taste solutions

    Primary outcome variables are intensity ratings of pediatric medications as well as a variety of generally recognized as safe bitter and non-bitter compounds.

    1-2 hours

Secondary Outcomes (1)

  • Maternal practices and perceptions of medication use

    1-2 hours

Study Arms (1)

Women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One hundred women who were previously enrolled in the study entitled "Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations," Protocol #809789; will be recruited for the current study

You may qualify if:

  • Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789)

You may not qualify if:

  • Women who are pregnant
  • Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Mennella JA, Mathew PS, Lowenthal ED. Use of Adult Sensory Panel to Study Individual Differences in the Palatability of a Pediatric HIV Treatment Drug. Clin Ther. 2017 Oct;39(10):2038-2048. doi: 10.1016/j.clinthera.2017.08.012. Epub 2017 Sep 18.

    PMID: 28923290DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

Study Officials

  • Julie A. Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

  • Elizabeth Lowenthal, MD MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member

Study Record Dates

First Submitted

April 24, 2013

First Posted

April 26, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

US(1)