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

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ClinicalTrials.gov Identifier: NCT00639587
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : September 4, 2009
Information provided by:
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Ketotifen Drug: Cetirizine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2002
Primary Completion Date : March 2003
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639587

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1-877-822-9493 (UCB)

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00639587     History of Changes
Other Study ID Numbers: A00275
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

Keywords provided by UCB Pharma:

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