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

Rhinitis, Allergic, Perennial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639587
• Other study ID #: A00275
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2008
• Last updated: September 3, 2009
• Start date: August 2002
• Est. completion date: March 2003

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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