Study Of Perennial Allergic Rhinitis In Pediatrics - Full Text View

Sponsor:	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

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
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

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

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

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00253058 History of Changes
Other Study ID Numbers:	104912, RPCE04E1101/A00381
Study First Received:	November 11, 2005
Last Updated:	October 5, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Perennial
Allergic
Rhinitis
pediatric

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine

Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012