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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 14, 2008

Last Updated Date

March 14, 2008

Start Date ^†

August 2002

Current Primary Outcome 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Rhinitis, Allergic, Perennial

Intervention ^†

Drug: Ketotifen
Drug: Cetirizine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

149

Completion Date

March 2003

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Both

Ages

7 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00639587

Responsible Party

Study Director, UCB

Secondary IDs ^††

Study Sponsor ^†

UCB

Collaborators ^††

Investigators ^†

Study Director:

UCB Clinical Trial Call Center

+1-877-822-9493 (UCB)

Information Provided By

UCB

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.