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

NCT00639587 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2009-09-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1-877-822-9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2003-03-31
Completion
2003-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639587 on ClinicalTrials.gov