- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00780403
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)
February 7, 2022 updated by: Organon and Co
A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 6-11 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RediTab/Zyrtec
Subjects 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.
|
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
Other Names:
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day
|
Active Comparator: Zyrtec/RediTab
Subjects 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.
|
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
Other Names:
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
Time Frame: Following the second dose (8-10 minutes after the first dose)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
October 23, 2008
First Submitted That Met QC Criteria
October 23, 2008
First Posted (Estimate)
October 27, 2008
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P04573
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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