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

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ClinicalTrials.gov Identifier: NCT00291642
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : February 10, 2017
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: Levocetirizine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : January 2006
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Evaluate efficacy of each active arm in reducing other SAR symptoms at different time points; the Safety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291642

Canada, Ontario
Kingston, Ontario, Canada
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00291642     History of Changes
Other Study ID Numbers: A00412
102837-Canada Health Auth.
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by UCB Pharma:
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents