Study Of Perennial Allergic Rhinitis In Pediatrics

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00253058

First received: November 11, 2005

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: Cetirizine Dry Syrup	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

Resource links provided by NLM:

Drug Information available for: Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

change in the total nasal symptom score (TNSS)

Secondary Outcome Measures:

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


Estimated Enrollment:	286
Study Start Date:	July 2005

Intervention Details:

Other Name: Cetirizine Dry Syrup

Eligibility


Ages Eligible for Study:	3 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253058

Locations


Spain
GSK Investigational Site
Unknown, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

No publications provided


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00253058 History of Changes
Other Study ID Numbers:	104912
Study First Received:	November 11, 2005
Last Updated:	May 3, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:


Allergic pediatric Rhinitis Perennial

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Cetirizine	Anti-Allergic Agents Histamine Agents Histamine Antagonists Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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