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”

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 allergic rhinitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2003

Intervention(s) in this Clinical Trial

• Drug: Ketotifen
  • Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
• Drug: Cetirizine
  • Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks

Primary Measures

• Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
  • Time Frame: TSS: 2 weeks - Safety: 3 weeks
    

Secondary Measures

• Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
  • Time Frame: T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period
    

Inclusion Criteria:

• 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 Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1-877-822-9493 (UCB)  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00639587

Study ID Number: A00275

ClinicalTrials.gov Identifier: NCT00639587

Health Authority: Japan: Ministry of Health, Labor and Welfare