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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 Pharma
ClinicalTrials.gov Identifier:
NCT00639587
First received: March 14, 2008
Last updated: September 3, 2009
Last verified: September 2009

March 14, 2008
September 3, 2009
August 2002
March 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00639587 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
March 2003
March 2003   (final data collection date for primary outcome measure)

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.
Both
7 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00639587
A00275
No
Study Director, UCB
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1-877-822-9493 (UCB)
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP