Study Of Perennial Allergic Rhinitis In Pediatrics - Tabular View

Tracking Information

First Received Date ^ICMJE

November 11, 2005

Last Updated Date

October 13, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

change in the total nasal symptom score (TNSS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00253058 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

Original Secondary Outcome Measures ^ICMJE

- Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

Descriptive Information

Brief Title ^ICMJE

Study Of Perennial Allergic Rhinitis In Pediatrics

Official Title ^ICMJE

Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

Brief Summary

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Perennial Allergic Rhinitis

Intervention ^ICMJE

Drug: Cetirizine Dry Syrup

Other Name: Cetirizine Dry Syrup

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

286

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

3 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00253058

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

104912, RPCE04E1101/A00381

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP