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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00639587
First received: March 14, 2008
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
 Drug: Ketotifen
Drug: Cetirizine
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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 ]

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 ]

Enrollment: 149
Study Start Date: August 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ketotifen
    Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
    Drug: Cetirizine
    Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639587

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1-877-822-9493 (UCB)
  More Information

No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00639587     History of Changes
Other Study ID Numbers: A00275
Study First Received: March 14, 2008
Last Updated: September 3, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB, Inc.:
Cetirizine
Zyrtec

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Cetirizine
 Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on May 16, 2013