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...
Date First Received: February 10, 2006
Last Updated: March 6, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 2 | Start Date: January 2006
Overall Status: Completed
Estimated Enrollment: 541
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Study Primary Completion Date: April 2006
Intervention(s) in this Clinical Trial
- Drug: Levocetirizine
Outcome Measures for this Clinical Trial
Primary 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 Measures
- Evaluate efficacy of each active arm in reducing other SAR symptoms at different time points; the Safety
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Marie-Etienne Pinelli, MD Study Chair UCB
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00291642
Study ID Number: A00412
ClinicalTrials.gov Identifier: NCT00291642
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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