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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00794794
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : September 22, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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.  

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
Study Start Date : November 2004
Primary Completion Date : November 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Taste flavor preference between bubble-gum, banana-grape, or grape flavors [ Time Frame: During the only study visit ]
  2. Adverse Events [ Time Frame: During the only study visit ]

Information from the National Library of Medicine

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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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00794794     History of Changes
Other Study ID Numbers: P03826
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 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