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

This study has been completed.

First Received: February 10, 2006 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
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

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.

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Cetirizine Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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, 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:	A00412, 102837-Canada Health Auth.
Study First Received:	February 10, 2006
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00291642 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by UCB, Inc.:

Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed

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
Histamine Antagonists
Respiratory Tract Diseases
Respiratory Tract Infections
Levocetirizine
Therapeutic Uses
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010