Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00291642

Purpose

The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of SAR in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.

Condition	Intervention	Phase
Rhinitis, Allergic, Seasonal	Drug: Levocetirizine	Phase II

MedlinePlus related topics: Hay Fever

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Five Parallel Groups, Exploratory Clinical Trial to Compare the Efficacy of Single Dose Levocetirizine 2.5 and 5 mg, Cetirizine 5 mg and 10 mg to Placebo in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen in a EEU.

Further study details as provided by UCB:

Primary Outcome Measures:

Compare efficacy of levocetirizine 2.5 mg, levocetirizine 5 mg, cetirizine 5 mg and cetirizine 10 mg vs placebo as measured by the mean change from baseline of major symptoms related to seasonal allergic rhinitis, in ragweed

Secondary Outcome Measures:

Evaluate efficacy of each active arm in reducing other SAR symptoms at different time points; the Safety

Estimated Enrollment:	541
Study Start Date:	January 2006
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol

Exclusion Criteria:

Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
Have used forbidden concomitant medications as defined by the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291642

Locations

Canada, Ontario

Kingston, Ontario, Canada

Sponsors and Collaborators

UCB

Investigators

Study Chair:

Marie-Etienne Pinelli, MD

UCB

More Information

Study ID Numbers:	A00412, 102837-Canada Health Auth.
Study First Received:	February 10, 2006
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00291642
Health Authority:	Canada: Health Canada

Keywords provided by UCB:

Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
SARS
Rhinitis
Cetirizine
Histamine
Hypersensitivity
Respiratory Tract Diseases

Respiratory Tract Infections
Levocetirizine
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Histamine Agents
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009