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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
History of Changes

November 11, 2005
May 3, 2013
July 2005
Not Provided
change in the total nasal symptom score (TNSS)
Same as current
Complete list of historical versions of study NCT00253058 on ClinicalTrials.gov Archive Site
- Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events
- Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events
Not Provided
Not Provided
 
Study Of Perennial Allergic Rhinitis In Pediatrics
Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
Drug: Cetirizine Dry Syrup
Other Name: Cetirizine Dry Syrup
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
Not Provided
Not Provided

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.
Both
3 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00253058
104912
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2013

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