PalatabilityNCT02233959
Palatability of a Novel Oral Formulation of Prednsione
An observational study of Palatability, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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 determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as… Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Palatability
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jan 2016
- Phase
- Observational
- 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 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32 years of age comprised of a convenience sample who meet study eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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 determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.
- Conditions
- Palatability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability of a new oral formulation of prednisone
We will create optimized shelf-stable prednisone microcapsules designed for complete taste-masking followed by immediate release in the stomach. Release characteristics of the TP will be compared to a pharmaceutical grade formulation of prednisone. Milestone: Microencapsulated prednisone that: (i) shows less than 10% coefficient of variance (CV) in the in vitro release profile between fresh and 4-week, 40°C stability-exposed samples while maintaining (ii) maximum of 5% total drug release during the initial 2 minutes and (iii) >90% release within 30 minutes.
N.B. This Specific Aim will be accomplished in the laboratories of Orbis Biosciences, Inc. Upon meeting all milestones associated with this SA, Orbis Biosciences will produce, in accordance with Good Laboratory and Manufacturing Principles, a single batch of TP suitable for use in accomplish SA2.
Measured: Immediately
Secondary outcomes (1)
Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP).
We will use a randomized cross-over design and a 9-Point Hedonic bipolar scale of scoring to compare the product appearance, smell, taste, mouth feel and after taste for three treatment groups: (i) Orbis's prednisone-loaded microcapsules (TP), developed in SA1, (ii) TP placebo microcapsules (i.e., delivery system not containing any active pharmaceutical ingredient or API), and (iii) the RP (Prednisone oral liquid, USP). We will suspend the microcapsules in a non-flavored suspension medium immediately before administration to healthy adults. The hypothesis associated with this SA is that microencapsulated prednisone (TP) will demonstrate significant improvement in organoleptic properties as compared to the RP.
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PalatabilityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis
- Responsible party
- Principal investigator, Greg Kearns, Arkansas Children's Hospital Research Institute
- Investigators
- Gregory L Kearns, Pharm D. PhD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233959
- Sponsor's protocol ID
- Orbis Palatability
- Status last verified
- Feb 2016
- First submitted
- 3 Sep 2014
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatability of a Novel Oral Formulation of Prednsione
- ClinicalTrials.gov ID
- NCT02233959
- Acronym / sponsor ID
- Orbis Palatability
- Conditions
- Palatability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Orbis
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Sep 2014 (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.
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 determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | – |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32 years of age comprised of a convenience sample who meet study eligibility criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Palatability of a new oral formulation of prednisone
Time frame: Immediately
We will create optimized shelf-stable prednisone microcapsules designed for complete taste-masking followed by immediate release in the stomach. Release characteristics of the TP will be compared to a pharmaceutical grade formulation of prednisone. Milestone: Microencapsulated prednisone that: (i) shows less than 10% coefficient of variance (CV) in the in vitro release profile between fresh and 4-week, 40°C stability-exposed samples while maintaining (ii) maximum of 5% total drug release during the initial 2 minutes and (iii) >90% release within 30 minutes. N.B. This Specific Aim will be accomplished in the laboratories of Orbis Biosciences, Inc. Upon meeting all milestones associated with this SA, Orbis Biosciences will produce, in accordance with Good Laboratory and Manufacturing Principles, a single batch of TP suitable for use in accomplish SA2.
1 secondary outcome
Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP).
Time frame: Immediately
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 18 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Gregory L Kearns, Pharm D. PhD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palatability, run by Arkansas Children's Hospital Research Institute 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 3 inclusion and 11 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 18 Feb 2016. 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.
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?
Palatability of a new oral formulation of prednisone (time frame: Immediately). 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 18 Feb 2016.