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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00639587

Purpose

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.

Condition	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: Ketotifen Drug: Cetirizine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Ketotifen Ketotifen fumarate Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Further study details as provided by UCB:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	149
Study Start Date:	August 2002
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Intervention Details:

Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks

Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks

Eligibility

Ages Eligible for Study:	7 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639587

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1-877-822-9493 (UCB)

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	A00275
Study First Received:	March 14, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00639587 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB:

Cetirizine
Zyrtec

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Rhinitis
Anti-Allergic Agents
Cetirizine
Histamine
Hypersensitivity
Ketotifen
Histamine Antagonists

Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Hypersensitivity, Immediate
Histamine phosphate
Antipruritics
Histamine H1 Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Rhinitis
Anti-Allergic Agents
Cetirizine
Pharmacologic Actions
Nose Diseases
Hypersensitivity

Ketotifen
Histamine Antagonists
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Hypersensitivity, Immediate
Histamine H1 Antagonists
Antipruritics
Histamine H1 Antagonists, Non-Sedating
Dermatologic Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 10, 2009