To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

This study has been completed.

First Received: September 4, 2007 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00525278

Purpose

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Condition	Intervention	Phase
Rhinitis Allergic Seasonal	Drug: Levocetirizine dihydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR)

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Loratadine Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Investigator rated T5SS (Total 5 symptom Score) over 2 weeks [ Time Frame: 2 weeks ]

Secondary Outcome Measures:

Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI). [ Time Frame: 2 weeks ]

Enrollment:	67
Study Start Date:	August 2003
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, 18 to 60 years old, inclusive
two-year history of allergic rhinitis due to tree, grass or weed pollen
sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

Exclusion Criteria:

An ear, nose or throat (ENT) infection
asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
an associated ENT disease
use of decongestants
nasal or ocular topical treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525278

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	A00348
Study First Received:	September 4, 2007
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00525278 History of Changes
Health Authority:	China: Department of Health, Pharmaceuticals registration and Import/Export control section

Keywords provided by UCB, Inc.:

Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Hypersensitivity
Loratadine
Respiratory Tract Infections
Respiratory Tract Diseases
Levocetirizine
Therapeutic Uses
Antipruritics
Dermatologic Agents
Otorhinolaryngologic Diseases

Immune System Diseases
Histamine Agents
Anti-Allergic Agents
Cetirizine
Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010