Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00794378

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Desloratadine (Clarinex) Drug: Cetirizine (Zyrtec)	Phase III

MedlinePlus related topics: Taste and Smell Disorders

Drug Information available for: Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment
Official Title:	A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face). [ Time Frame: During the only study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Taste flavor preference between bubble-gum, banana-grape, or grape flavors [ Time Frame: During the only study visit ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: During the only study visit ] [ Designated as safety issue: Yes ]

Enrollment:	202
Study Start Date:	November 2004
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Desloratadine and Cetirizine Crossover: Experimental To compare the preference in taste between desloratadine and cetirizine.	Drug: Desloratadine (Clarinex) Each subject received 5 mL of desloratadine syrup one time Drug: Cetirizine (Zyrtec) Each subject received 5 mL of cetirizine syrup

Detailed Description:

This study is a cross-over study design.

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03829
Study First Received:	November 19, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00794378
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Histamine phosphate

Rhinitis
Cetirizine
Desloratadine
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Histamine Agents
Anti-Allergic Agents
Cholinergic Agents

Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Therapeutic Uses
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on January 14, 2009