Status:
COMPLETED
Palatability of a Novel Oral Formulation of Prednsione
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
Orbis
Conditions:
Palatability
Eligibility:
All Genders
18-32 years
Brief Summary
Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important de...
Eligibility Criteria
Inclusion
- age 18 to 32 years, male and female who are healthy at the time of study
- can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
- demonstrate ability to complete study questionnaire
Exclusion
- history of smoking or using any tobacco products
- previous history of taste disturbance
- any condition or dietary habit known to interfere with the sense of smell and taste
- any structural or functional abnormality of the upper gastrointestinal tract
- ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
- history of any significant illness within the two weeks prior to study
- history of autonomic dysfunction, bronchospastic disease or atopic allergy
- known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
- any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
- brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
- inability to speak and/or read English at a grade 10 level
Key Trial Info
Start Date :
December 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02233959
Start Date
December 1 2015
End Date
January 1 2016
Last Update
February 18 2016
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108