NCT00794378

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

Same day

First QC Date

November 19, 2008

Last Update Submit

February 7, 2022

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).

    During the only study visit

Secondary Outcomes (2)

  • Taste flavor preference between bubble-gum, banana-grape, or grape flavors

    During the only study visit

  • Adverse Events

    During the only study visit

Study Arms (1)

Desloratadine and Cetirizine Crossover

EXPERIMENTAL

To compare the preference in taste between desloratadine and cetirizine.

Drug: Desloratadine (Clarinex)Drug: Cetirizine (Zyrtec)

Interventions

Desloratadine (Clarinex)DRUG

Each subject received 5 mL of desloratadine syrup one time

Also known as: SCH 034117, Clarinex
Desloratadine and Cetirizine Crossover
Cetirizine (Zyrtec)DRUG

Each subject received 5 mL of cetirizine syrup

Also known as: Zyrtec
Desloratadine and Cetirizine Crossover

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects must be:
  • Between 6 and 11 years of age in good general health
  • Premenarcheal if female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

desloratadineCetirizine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

November 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

February 16, 2022

Record last verified: 2022-02