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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
  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:


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:
    Drug: Cetirizine Dry Syrup
    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 November 20, 2014