CUTE (Chronic Urticaria Treatment Evaluation)

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

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, 4 week duration

Primary Measures

• Mean Pruritus Severity Score Over the First Week of Treatment
  • Time Frame: over the first week of treatment
    Safety Issue?: No

Secondary Measures

• Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
  • Time Frame: over the first week of treatment
    Safety Issue?: No
• Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
  • Time Frame: over the four weeks of treatment
    Safety Issue?: No
• Mean Pruritus Severity Score Over the Four Weeks of Treatment
  • Time Frame: over the four weeks of treatment
    Safety Issue?: No
• Mean Score for Pruritus Duration Over the First Week of Treatment
  • Time Frame: over the first week of treatment
    Safety Issue?: No
• Mean Score for Pruritus Duration Over the Four Weeks of Treatment
  • 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 Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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

FDA Safety Alerts and Recalls

Product Information