Last updated: 11/03/2018 07:46:57
Study Of Perennial Allergic Rhinitis In Pediatrics
GSK study ID
104912
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering from Perennial Allergic Rhinitis-
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
286
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Perennial
Product
cetirizine
Collaborators
Not applicable
Study date(s)
July 2005 to December 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
3 - 14 years
Accepts healthy volunteers
No
- Children with perennial allergic rhinitis.
- Giving informed consent.
- have spastic disease such as epilepsy
- have a history of drug hypersensitivity
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-02-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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