NCT00639587

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-08-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2008-03-20
• Last updated: 2009-09-04