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Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00794378
First received: November 19, 2008
Last updated: July 3, 2014
Last verified: July 2014

November 19, 2008
July 3, 2014
November 2004
November 2004   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00794378 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)
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.

This study is a cross-over study design.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Allergic Rhinitis
  • Drug: Desloratadine (Clarinex)
    Each subject received 5 mL of desloratadine syrup one time
    Other Name: SCH 034117, Clarinex
  • Drug: Cetirizine (Zyrtec)
    Each subject received 5 mL of cetirizine syrup
    Other Name: Zyrtec
Experimental: Desloratadine and Cetirizine Crossover
To compare the preference in taste between desloratadine and cetirizine.
Interventions:
  • Drug: Desloratadine (Clarinex)
  • Drug: Cetirizine (Zyrtec)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
November 2004
November 2004   (final data collection date for primary outcome measure)

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
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00794378
P03829
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP