Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)
A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications
1 other identifier
interventional
220
0 countries
N/A
Brief Summary
The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2005
Shorter than P25 for phase_4
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
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 23, 2008
CompletedFirst Posted
Study publicly available on registry
October 27, 2008
CompletedResults Posted
Study results publicly available
July 30, 2010
CompletedFebruary 9, 2022
February 1, 2022
2 months
October 23, 2008
February 17, 2010
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.
Following the second dose (8-10 minutes after the first dose)
Study Arms (2)
RediTab/Zyrtec
ACTIVE COMPARATORSubjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference.
Zyrtec/RediTab
ACTIVE COMPARATORSubjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.
Interventions
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day
Eligibility Criteria
You may qualify if:
- Subject and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent
- years old, either sex, either race
- If female, subject to be premenarcheal
- Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
- Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
- Able to adhere to the dosing and visit schedules
You may not qualify if:
- If female, subject who was pregnant, intended to become pregnant during the study or nursing.
- Subject had used any investigational product within 30 days prior to enrollment.
- Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
- Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
- Subject was participating in any other clinical study(ies).
- Subject was part of the staff or a family member of the staff personnel directly involved with this study.
- Subject was allergic to or has sensitivity to the study drug or its excipients.
- Subject had a history of allergic reaction to prescription and/or over the counter (OTC) medications and/or food products.
- Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.
- Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2008
First Posted
October 27, 2008
Study Start
August 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
February 9, 2022
Results First Posted
July 30, 2010
Record last verified: 2022-02