Perennial Allergic Rhinitis In Pediatric Subjects | NCT00257595

Studies
Perennial Allergic Rhinitis In Pediatric Subjects

NCT00257595

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 6, 2013Estimated

Enrollment

Phase

Phase 3

Conditions

Rhinitis, Allergic, Perennial

Interventions

Cetirizine Dry Syrup

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

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 21, 2005

First Submission Date that Met QC Criteria

Nov 22, 2005

First Posted Date

Nov 23, 2005Estimated

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

May 3, 2013

Last Update Posted Date

May 6, 2013Estimated

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

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

Name	Type	Description	Arm Group Labels	Other Names
Cetirizine Dry Syrup	Drug

Measure	Description	Time Frame
safety

Measure	Description	Time Frame
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with perennial allergic rhinitis.
Giving informed consent.
Children with a positive response to specific IgE antibody test.
Children assessed as positive in the nasal eosinophil count.
Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

have a history of drug hypersensitivity.
are pregnant, lactating or possibly pregnant female children.
Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
have vasomotor rhinitis and eosinophilic rhinitis.
have asthma that requires the treatment with corticosteroid.
have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.
have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.
have started specific desensitization treatment.
nonspecific modulation treatment but who have not reached the maintenance level of treatment.
have received surgical treatment for reduction and modulation of nasal mucosa.
redintegration therapy of nasal cavity to improve the degree of nasal airway.
surgical operation to improve rhinorrhea.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided