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

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ClinicalTrials.gov Identifier: NCT00794378
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00794378     History of Changes
Other Study ID Numbers: P03829
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Loratadine
Cetirizine
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
Antipruritics
Dermatologic Agents
Anti-Allergic Agents