Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal
Intervention: Levocetirizine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Marie-Etienne Pinelli, MD, Study Chair, Affiliation: UCB
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: 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: Evaluate efficacy of each active arm in reducing other SAR symptoms at different time points; the Safety
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kingston, Ontario, Canada
Additional Information
Starting date: January 2006
Ending date: April 2006
Last updated: March 6, 2008
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