Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00639587

Collaborator

(none)

149

Enrollment

Duration (Months)

Study Details

Study Description

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 versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Perennial	Drug: Ketotifen Drug: Cetirizine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Mar 1, 2003

Actual Study Completion Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.