Perennial Allergic Rhinitis In Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257595
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2013
Information provided by (Responsible Party):

November 21, 2005
November 23, 2005
May 6, 2013
August 2005
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Same as current
Complete list of historical versions of study NCT00257595 on Archive Site
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
  • Total Nasal Symptom Score (TNSS)
  • Individual nasal symptom score
  • Total score of 4 individual daily symptom scores
  • Investigator global improvement rating
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Perennial Allergic Rhinitis In Pediatric Subjects
Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
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Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
Drug: Cetirizine Dry Syrup
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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 a history of drug hypersensitivity.
  • are pregnant, lactating or possibly pregnant female children.
  • Sensitivity 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.
  • 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.
Sexes Eligible for Study: All
2 Years to 14 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Study Director: GSK Clinical Trials GlaxoSmithKline
May 2013

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