Status:
COMPLETED
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
Lead Sponsor:
UCB Pharma
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
7-14 years
Phase:
PHASE3
Brief Summary
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versu...
Eligibility Criteria
Inclusion
- had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
- severity of nasal symptoms was moderate to severe during the observation period;
- criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.
Exclusion
- history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
- history of drug hypersensitivity;
- history of convulsive disorder;
- vasomotor rhinitis or eosinophilic rhinitis;
- asthma requiring treatment with adrenocortical hormones;
- concomitant diseases which could impede the efficacy evaluation of the study drug;
- subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage;
- pollen allergy;
- malignant neoplasm.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00639587
Start Date
August 1 2002
End Date
March 1 2003
Last Update
September 4 2009
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