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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639587

Enrollment

149

Registered

2008-03-20

Start date

2002-08-31

Completion date

2003-03-31

Last updated

2009-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

Cetirizine, Zyrtec

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.

Interventions

DRUGKetotifen

Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks

DRUGCetirizine

Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

7 Years to 14 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026