Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Perennial
Intervention: Ketotifen (Drug); Cetirizine (Drug)
Phase: Phase 3
Sponsored by: UCB
Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1-877-822-9493 (UCB)
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 versus ketotifen dry syrup on children 7 years and older with perennial
Official title: A Double-Blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results)
Safety: adverse events and laboratory assessments
Secondary outcome: Total 2 symptoms score (T2SS) (sneezing, nasal discharge)
Global Improvement Rating
Minimum age: 7 Years.
Maximum age: 14 Years.
- 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.
- 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.
Locations and Contacts
Starting date: August 2002
Ending date: March 2003
Last updated: March 14, 2008