Study Of Perennial Allergic Rhinitis In Pediatrics

NCT ID: NCT00253058

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period

Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cetirizine Dry Syrup

Intervention Type DRUG

Eligibility Criteria

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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 spastic disease such as epilepsy
* have a history of drug hypersensitivity
* are pregnant, lactating or possibly pregnant female Children
* are sensitive 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 or 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

, ,

Site Status

Countries

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Other Identifiers

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104912

Identifier Type: -

Identifier Source: org_study_id

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