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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

Expanded Access : 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.

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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
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00794794    
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:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents