NCT01734759

Brief Summary

The purpose of this study is to see if a medication taste test influences the prescribing habits of pediatric prescribers at Mayo Clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1 healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

November 17, 2012

Last Update Submit

October 18, 2013

Conditions

Keywords

medication palatabilitymedication taste

Outcome Measures

Primary Outcomes (1)

  • Taste scores on the visual analog scale

    Medication taste scores on the visual analog scale before and after a medication tasting will be measured.

    Change from baseline in taste scores at 3 months

Study Arms (1)

Taste Test

EXPERIMENTAL
Drug: Taste Test

Interventions

Before the taste test each participant will fill out an informed consent form and an enrollment survey. Each participant will receive 0.5 mL of each study medication in the taste test. During the taste test each medication in a class will be labeled with a color name so as to prevent any bias from preconceived taste perception. They will record their perception of the medications taste on a visual analog scale (VAS). An anaphlyaxis kit will be on hand in case of emergencies. Between samples participants will cleanse their palate with a saltine cracker and 30 mL of water. 5 different classes of medications will be tested. Medications to be sampled and the corresponding dose of the test dose are: * Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg * Penicillins: penicillin VK 12.5 mg, amoxicillin 12.5 mg * Analgesic/antipyretics: acetaminophen 16 mg, ibuprofen 10 mg * Steroids: prednisolone 1.5 mg, prednisone 0.5 mg * H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg

Taste Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects possess prescriptive authority (e.g. MD, nurse practitioner, physician's assistant, medication therapy management pharmacists)
  • subjects have prescribed at least one of the study medications from one of the medication classes to pediatric patients at an outpatient clinic in the three months preceding the study

You may not qualify if:

  • subjects do not prescribe any of the tested medications
  • subject has an allergy to all of the study medications
  • subject is pregnant or breastfeeding
  • subject has a medical condition that prevents them from being involved in the taste test
  • Participants are advised to be within or accessible to the Rochester, MN area during study recruitment and accessible afterwards via mail, email or fax.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Bernard Lee, PharmD, RPh

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Ole J Olson, Pharm.D., BCPS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Michelle J LoTurco, Pharm.D.

    Mayo Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 17, 2012

First Posted

November 28, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations