- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794378
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)
February 7, 2022 updated by: Organon and Co
A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children.
Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a cross-over study design.
Study Type
Interventional
Enrollment (Actual)
202
Phase
- Phase 3
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:
Subjects must be:
- Between 6 and 11 years of age in good general health
- Premenarcheal if female
Exclusion Criteria:
Subjects who:
- Have known allergies or sensitivities to either of the drug formulations
- Have a medical condition that may interfere with the subject's ability to discriminate between tastes
- Have used any antihistamines within 24 hours prior to dosing
- Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
- Were involved in another clinical or market research study within the past 30 days
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desloratadine and Cetirizine Crossover
To compare the preference in taste between desloratadine and cetirizine.
|
Each subject received 5 mL of desloratadine syrup one time
Other Names:
Each subject received 5 mL of cetirizine syrup
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
Time Frame: During the only study visit
|
During the only study visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Taste flavor preference between bubble-gum, banana-grape, or grape flavors
Time Frame: During the only study visit
|
During the only study visit
|
Adverse Events
Time Frame: During the only study visit
|
During the only study visit
|
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
November 1, 2004
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
November 19, 2008
First Submitted That Met QC Criteria
November 19, 2008
First Posted (Estimate)
November 20, 2008
Study Record Updates
Last Update Posted (Actual)
February 16, 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
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
- Desloratadine
Other Study ID Numbers
- P03829
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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