A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of...
Date First Received: December 8, 2005
Last Updated: March 6, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 816
Brief Summary
Official Title: “A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)”
Condition Keyword(s):
Intervention(s):
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Study Primary Completion Date: January 2007
Intervention(s) in this Clinical Trial
- Drug: Levocetirizine
Outcome Measures for this Clinical Trial
Primary Measures
- Mean pruritus severity score over the first week of treatment
Secondary Measures
- Mean CIU composite score over the first and over the four weeks of treatment, mean pruritus severity score over four weeks of treatment, mean score for pruritus duration, number and size of wheals over the first and past over the four weeks of treatment,
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause
- At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.
Exclusion Criteria:
- Any condition that would interfere with the evaluation of the therapeutic response.
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 Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00264303
Study ID Number: A00394
ClinicalTrials.gov Identifier: NCT00264303
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Clinical Trials Authorship and Review
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