Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00794378
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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

Schering-Plough 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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 202
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.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00794378     History of Changes
Other Study ID Numbers: P03829
Study First Received: November 19, 2008
Last Updated: November 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cetirizine
Loratadine
Desloratadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
 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
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013