HealthyPhase 1NCT01734759
Influence of Medication Taste on Pediatric Prescribers' Prescribing Habits
A Phase 1 study testing Taste Test in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if a medication taste test influences the prescribing habits of pediatric prescribers at Mayo Clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Taste Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Influence of Medication Palatability on Prescribing Habits of Pediatric Prescribers
The purpose of this study is to see if a medication taste test influences the prescribing habits of pediatric prescribers at Mayo Clinic.
- Conditions
- Healthy
- Being tested
- Taste Test
- Keywords
- medication palatability, medication taste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste TestDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Taste Test | Experimental | Not described Receives: Drug: Taste Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste scores on the visual analog scale
Medication taste scores on the visual analog scale before and after a medication tasting will be measured.
Measured: Change from baseline in taste scores at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Lee, Mayo Clinic
- Investigators
- Bernard Lee, PharmD, RPh, Principal investigator, Mayo ClinicOle J Olson, Pharm.D., BCPS, Principal investigator, Mayo ClinicMichelle J LoTurco, Pharm.D., Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734759
- Sponsor's protocol ID
- 12-005823
- Status last verified
- Oct 2013
- First submitted
- 17 Nov 2012
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medication Palatability on Prescribing Habits of Pediatric Prescribers
- ClinicalTrials.gov ID
- NCT01734759
- Acronym / sponsor ID
- 12-005823
- Conditions
- Healthy
- Keywords
- medication palatability, medication taste
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if a medication taste test influences the prescribing habits of pediatric prescribers at Mayo Clinic.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taste Test | Experimental | Drug: Taste Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taste TestBefore 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 | Drug | Taste Test |
Primary outcome
Taste scores on the visual analog scale
Time frame: Change from baseline in taste scores at 3 months
Medication taste scores on the visual analog scale before and after a medication tasting will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Lee, PharmD, RPh principal investigator
Mayo Clinic
Ole J Olson, Pharm.D., BCPS principal investigator
Mayo Clinic
Michelle J LoTurco, Pharm.D. study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Taste Test in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste scores on the visual analog scale (time frame: Change from baseline in taste scores at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.