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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Ketotifen

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

Intervention Type DRUG

Cetirizine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No