Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of...
Date First Received: September 8, 2005
Last Updated: March 6, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2005
Overall Status: Completed
Estimated Enrollment: 200
Brief Summary
Official Title: “A Monocenter, Double-Blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen”
Condition Keyword(s):
Intervention(s):
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment
Study Type: Interventional
Study Design: Randomized, Double-Blind, Active Control, Parallel Assignment
Study Primary Completion Date: July 2005
Intervention(s) in this Clinical Trial
- Drug: Levocetirizine
Outcome Measures for this Clinical Trial
Primary Measures
- Subjects' satisfaction / dissatisfaction after the first week of treatment.
Secondary Measures
- allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Clinical history of SAR known and treated since 2 years.
- Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5
- IU/ml) to grass pollen (less than 1 year).
- Minimum mean T5SS of 8 during the baseline period.
Exclusion Criteria:
- Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
- Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Krassimir Mitchev, MD, PhD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160537
Study ID Number: A00391
ClinicalTrials.gov Identifier: NCT00160537
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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