Taste Test Between Desloratadine and Cetirizine Syrup in... | NCT00794378

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

NCT00794378

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 16, 2022Actual

Enrollment

202Actual

Phase

Phase 3

Conditions

Allergic Rhinitis

Interventions

Desloratadine (Clarinex)
Cetirizine (Zyrtec)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Yes

Start Date

Nov 2004

Primary Completion Date

Nov 2004Actual

Completion Date

Nov 2004Actual

First Submitted Date

Nov 19, 2008

First Submission Date that Met QC Criteria

Nov 19, 2008

First Posted Date

Nov 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2022

Last Update Posted Date

Feb 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is a cross-over study design.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Desloratadine and Cetirizine Crossover	Experimental	To compare the preference in taste between desloratadine and cetirizine.	Drug: Desloratadine (Clarinex) Drug: Cetirizine (Zyrtec)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Desloratadine (Clarinex)	Drug	Each subject received 5 mL of desloratadine syrup one time	Desloratadine and Cetirizine Crossover

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).		During the only study visit

Secondary Outcomes

Measure	Description	Time Frame
Taste flavor preference between bubble-gum, banana-grape, or grape flavors		During the only study visit
Adverse Events		During the only study visit

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C121345	desloratadine
D017332	Cetirizine

Ancestor Terms

ID	Term
D006919	Hydroxyzine
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided