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
1 other identifier
interventional
149
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2002
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedSeptember 4, 2009
September 1, 2009
7 months
March 14, 2008
September 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
TSS: 2 weeks - Safety: 3 weeks
Secondary Outcomes (1)
Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period
Interventions
Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1-877-822-9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2008
First Posted
March 20, 2008
Study Start
August 1, 2002
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
September 4, 2009
Record last verified: 2009-09