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OpenTrials
Completed

NCT Number: NCT00639587

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

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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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketotifen

Drug

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

Cetirizine

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 20, 2008
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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