Perennial Allergic Rhinitis In Pediatric Subjects
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perennial Allergic Rhinitis
Intervention: Cetirizine Dry Syrup (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
To assess the safety of long-term use of cetirizine dry syrup in children with perennial
allergic rhinitis.
Clinical Details
Official title: Long-Term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: safety
Secondary outcome: Total Nasal Symptom Score (TNSS)
Individual nasal symptom score
total score of 4 individual daily symptom scores
Investigator global improvement rating
Eligibility
Minimum age: 2 Years.
Maximum age: 14 Years.
Gender(s): Both.
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 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.
Locations and Contacts
GSK Clinical Trials Call Center, Fukuoka_18 812, Japan
GSK Clinical Trials Call Center, Yamanashi_16 400, Japan
GSK Clinical Trials Call Center, Gunma_1 370, Japan
GSK Clinical Trials Call Center, Chiba_2 261, Japan
GSK Clinical Trials Call Center, Chiba_3 272, Japan
GSK Clinical Trials Call Center, Chiba_4 279, Japan
GSK Clinical Trials Call Center, Chiba_5 272, Japan
GSK Clinical Trials Call Center, Tokyo_6 101, Japan
GSK Clinical Trials Call Center, Tokyo_7 140, Japan
GSK Clinical Trials Call Center, Tokyo_8 173, Japan
GSK Clinical Trials Call Center, Kanagawa_9 222, Japan
GSK Clinical Trials Call Center, Kanagawa_10 224, Japan
GSK Clinical Trials Call Center, Kanagawa_11 224, Japan
GSK Clinical Trials Call Center, Kanagawa_12 229, Japan
GSK Clinical Trials Call Center, Kanagawa_14 213, Japan
GSK Clinical Trials Call Center, Yamanashi_15 406, Japan
GSK Clinical Trials Call Center, Kanagawa_13 240, Japan
GSK Clinical Trials Call Center, Shizuoka_17 420, Japan
Additional Information
Starting date: July 2005
Last updated: July 31, 2007
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