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)”

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, Safety/Efficacy Study

Study Primary Completion Date: January 2007

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine
  • 5mg oral capsules, once daily, 4 week duration
• Drug: Desloratadine
  • 5mg oral capsules, once daily, 4 week duration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levocetirizine
  • Levocetirizine, once daily, 4 week duration
• Active Comparator: Desloratadine
  • desloratadine once daily for four weeks

Primary Measures

• Mean pruritus severity score
  • Time Frame: over the first week of treatment
    Safety Issue?: No

Secondary Measures

• Mean CIU composite score
  • Time Frame: over the first week of treatment
    Safety Issue?: No
• Mean CIU composite score
  • Time Frame: over the four weeks of treatment
    Safety Issue?: No
• Mean pruritus severity score
  • Time Frame: over the four weeks of treatment
    Safety Issue?: No
• Mean score for pruritus duration
  • Time Frame: over the first week of treatment
    Safety Issue?: No
• Mean score for pruritus duration
  • Time Frame: over the four weeks of treatment
    Safety Issue?: No

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

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Information obtained from ClinicalTrials.gov on July 02, 2009

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