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Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 19, 2008
Last updated: September 21, 2015
Last verified: September 2015
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 3

Merck Sharp & Dohme Corp. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Secondary Outcome Measures:
  • Taste flavor preference between bubble-gum, banana-grape, or grape flavors [ Time Frame: During the only study visit ]
  • Adverse Events [ Time Frame: During the only study visit ]

Enrollment: 204
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
Experimental: Desloratadine and Cetirizine Crossover
To compare the preference in taste between desloratadine and cetirizine.
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

Detailed Description:
This study is a cross-over study design.

Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00794794     History of Changes
Other Study ID Numbers: P03826
Study First Received: November 19, 2008
Last Updated: September 21, 2015

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on April 24, 2017