CUTE (Chronic Urticaria Treatment Evaluation)

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Chronic Idiopathic Urticaria

Intervention / Treatment
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* Drug: Levocetirizine
* Drug: Desloratadine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levocetirizine<br>Levocetirizine, once daily, 4 week duration | Drug: Levocetirizine<br>* 5mg oral capsules, once daily, 4 week duration<br>|
| Active Comparator: Desloratadine<br>Desloratadine, once daily, 4 week duration | Drug: Desloratadine<br>* 5mg oral capsules, once daily, 4 week duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pruritus Severity Score Over the First Week of Treatment | Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment. | over the first week of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment | CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment. | over the first week of treatment | 
| Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment | CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment. | over the four weeks of treatment | 
| Mean Pruritus Severity Score Over the Four Weeks of Treatment | Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment. | over the four weeks of treatment | 
| Mean Score for Pruritus Duration Over the First Week of Treatment | The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment. | over the first week of treatment | 
| Mean Score for Pruritus Duration Over the Four Weeks of Treatment | The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment. | over the four weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Idiopathic Urticaria, CUTE Levocetirizine Xyzal®