<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233959</url>
  </required_header>
  <id_info>
    <org_study_id>Orbis Palatability</org_study_id>
    <nct_id>NCT02233959</nct_id>
  </id_info>
  <brief_title>Palatability of a Novel Oral Formulation of Prednsione</brief_title>
  <official_title>Palatability of a Novel Oral Formulation of Prednsione</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orbis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone&#xD;
      to pediatric and adult patients. The rationale for this study is that palatability is the&#xD;
      most important determinant of pediatric patient compliance, and therefore, it is critical&#xD;
      that the Orbis formulation be perceived as significantly more palatable compared to today's&#xD;
      commercially available products in order to warrant further development of the TP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Palatability of a new oral formulation of prednisone</measure>
    <time_frame>Immediately</time_frame>
    <description>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) &gt;90% release within 30 minutes.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP).</measure>
    <time_frame>Immediately</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Palatability</condition>
  <arm_group>
    <arm_group_label>Healthy Adults</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32&#xD;
        years of age comprised of a convenience sample who meet study eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 to 32 years, male and female who are healthy at the time of study&#xD;
&#xD;
          -  can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing&#xD;
             and then expectorate contents into a cup&#xD;
&#xD;
          -  demonstrate ability to complete study questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of smoking or using any tobacco products&#xD;
&#xD;
          -  previous history of taste disturbance&#xD;
&#xD;
          -  any condition or dietary habit known to interfere with the sense of smell and taste&#xD;
&#xD;
          -  any structural or functional abnormality of the upper gastrointestinal tract&#xD;
&#xD;
          -  ingestion of any medication or nutritional supplement (with exception of acetaminophen&#xD;
             tablets or capsules) in a 48 hour period prior to study&#xD;
&#xD;
          -  history of any significant illness within the two weeks prior to study&#xD;
&#xD;
          -  history of autonomic dysfunction, bronchospastic disease or atopic allergy&#xD;
&#xD;
          -  known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or&#xD;
             artificial sweetener&#xD;
&#xD;
          -  any history of participating in a clinical trial of a drug or device within a 30 day&#xD;
             period from the time of study&#xD;
&#xD;
          -  brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance&#xD;
             within two hours of receipt of the initial test article and&#xD;
&#xD;
          -  inability to speak and/or read English at a grade 10 level&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>32 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory L Kearns, Pharm D. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 16, 2016</last_update_submitted>
  <last_update_submitted_qc>February 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arkansas Children's Hospital Research Institute</investigator_affiliation>
    <investigator_full_name>Greg Kearns</investigator_full_name>
    <investigator_title>Senior Vice President and Chief Research Officer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233959
org study id: Orbis Palatability
nct id: NCT02233959
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Palatability of a new oral formulation of prednisone
time frame: Immediately
description: 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.
measure: 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
description: 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.
arm group label: Healthy Adults
Whole Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 32 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory L Kearns, Pharm D. PhD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Arkansas Children's Hospital Research Institute
investigator full name: Greg Kearns
investigator title: Senior Vice President and Chief Research Officer
sharing ipd: Undecided