Phase 4
Completed N=886
CUTE (Chronic Urticaria Treatment Evaluation)
Chronic Idiopathic Urticaria
Source: ClinicalTrials.gov NCT00264303 ↗
Enrolled (actual)
886
Serious AEs
0.2%
Results posted
Jul 2009
Primary outcomePrimary: Mean Pruritus Severity Score Over the First Week of Treatment — 1.02; 1.18 Units on a scale — p=<0.001
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pruritus Severity Score Over the First Week of Treatment |
1.02; 1.18 | <0.001 sig |
| SECONDARY Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment |
1.98; 2.23 | 0.005 sig |
| SECONDARY Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment |
1.71; 1.88 | 0.041 sig |
| SECONDARY Mean Pruritus Severity Score Over the Four Weeks of Treatment |
0.86; 0.99 | 0.004 sig |
| SECONDARY Mean Score for Pruritus Duration Over the First Week of Treatment |
1.08; 1.24 | 0.002 sig |
| SECONDARY Mean Score for Pruritus Duration Over the Four Weeks of Treatment |
0.93; 1.05 | 0.009 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00264303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.