Who is sponsoring NCT00639587?

NCT00639587 is sponsored by UCB Pharma.

What condition does NCT00639587 study?

NCT00639587 studies Rhinitis, Allergic, Perennial.

What drugs are being tested in NCT00639587?

Interventions: Ketotifen, Cetirizine.

What is the status of NCT00639587?

NCT00639587 is currently COMPLETED.

Last reviewed 2009-09-03 · How we verify

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

NCT00639587 Phase 3 COMPLETED

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.

Details

Lead sponsor	UCB Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	149
Start date	2002-08
Completion	2003-03

Conditions

Rhinitis, Allergic, Perennial

Interventions

Ketotifen
Cetirizine

Primary outcomes

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