Study Of Perennial Allergic Rhinitis In Pediatrics - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00253058

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
Perennial Allergic Rhinitis	Drug: Cetirizine Dry Syrup	Phase III

MedlinePlus related topics: Children's Health

Drug Information available for: Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

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

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

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104912, RPCE04E1101/A00381
Study First Received:	November 11, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00253058
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Perennial
Allergic
Rhinitis
pediatric

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate

Histamine phosphate
Rhinitis
Cetirizine
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Histamine Agents
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009