Back to resultsCUTE (Chronic Urticaria Treatment Evaluation)
Primary Purpose
Chronic Idiopathic Urticaria
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Levocetirizine
Desloratadine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria focused on measuring Chronic Idiopathic Urticaria, CUTE Levocetirizine Xyzal®
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levocetirizine
Desloratadine
Arm Description
Levocetirizine, once daily, 4 week duration
Desloratadine, once daily, 4 week duration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00264303
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
Keywords
Chronic Idiopathic Urticaria, CUTE Levocetirizine Xyzal®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
886 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levocetirizine
Arm Type
Experimental
Arm Description
Levocetirizine, once daily, 4 week duration
Arm Title
Desloratadine
Arm Type
Active Comparator
Arm Description
Desloratadine, once daily, 4 week duration
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Intervention Description
5mg oral capsules, once daily, 4 week duration
Intervention Type
Drug
Intervention Name(s)
Desloratadine
Intervention Description
5mg oral capsules, once daily, 4 week duration
Primary Outcome Measure Information:
Title
Mean Pruritus Severity Score Over the First Week of Treatment
Description
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.
Time Frame
over the first week of treatment
Secondary Outcome Measure Information:
Title
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
Description
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.
Time Frame
over the first week of treatment
Title
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
Description
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.
Time Frame
over the four weeks of treatment
Title
Mean Pruritus Severity Score Over the Four Weeks of Treatment
Description
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.
Time Frame
over the four weeks of treatment
Title
Mean Score for Pruritus Duration Over the First Week of Treatment
Description
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.
Time Frame
over the first week of treatment
Title
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
Description
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.
Time Frame
over the four weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Brugge
Country
Belgium
City
Brussels
Country
Belgium
City
Liege
Country
Belgium
City
Merksem
Country
Belgium
City
Sint-Niklaas
Country
Belgium
City
Woluwe-St-Lamb
Country
Belgium
City
Bernay
Country
France
City
Besancon
Country
France
City
Hyeres
Country
France
City
Les Milles
Country
France
City
Marseille
Country
France
City
Montpellier
Country
France
City
Nancy
Country
France
City
Nantes
Country
France
City
Nice
Country
France
City
Nimes
Country
France
City
Paris
Country
France
City
Poitiers
Country
France
City
Quimper
Country
France
City
Saint-Mande
Country
France
City
Troyes
Country
France
City
Valence
Country
France
City
Villejuif
Country
France
City
Augsburg
Country
Germany
City
Berlin
Country
Germany
City
Dresden
Country
Germany
City
Dusseldorf
Country
Germany
City
Erlangen
Country
Germany
City
Gottingen
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Koln
Country
Germany
City
Leipzig
Country
Germany
City
Mahlow
Country
Germany
City
Mainz
Country
Germany
City
Munchen
Country
Germany
City
Viersen
Country
Germany
City
Caserta
Country
Italy
City
Catania
Country
Italy
City
Cesena
Country
Italy
City
Genova
Country
Italy
City
Modena
Country
Italy
City
Palermo
Country
Italy
City
Pavia
Country
Italy
City
Roma
Country
Italy
City
Siena
Country
Italy
City
Udine
Country
Italy
City
Verona
Country
Italy
City
Johor Bharu
Country
Malaysia
City
Kelantan
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Negeri Sembilan
Country
Malaysia
City
Perak
Country
Malaysia
City
Pulau Pinang
Country
Malaysia
City
Sarawak
Country
Malaysia
City
Brasov
Country
Romania
City
Bucharest
Country
Romania
City
Dolj
Country
Romania
City
Sibiu
Country
Romania
City
Cape Town
Country
South Africa
City
Durban
Country
South Africa
City
Lenasia
Country
South Africa
City
Albacete
Country
Spain
City
Barcelona
Country
Spain
City
Coruna
Country
Spain
City
Granada
Country
Spain
City
Madrid
Country
Spain
City
Malaga
Country
Spain
City
Murcia (El Palmar)
Country
Spain
City
Oviedo
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Sevila
Country
Spain
City
Valencia
Country
Spain
City
Amersham
Country
United Kingdom
City
Cardiff
Country
United Kingdom
City
Irvine
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
London
Country
United Kingdom
City
Nuneaton
Country
United Kingdom
City
Salford
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
CUTE (Chronic Urticaria Treatment Evaluation)
We'll reach out to this number within 24 hrs