CUTE (Chronic Urticaria Treatment Evaluation)
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)
3 other identifiers
interventional
886
9 countries
80
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2005
Shorter than P25 for phase_4
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 8, 2005
CompletedFirst Posted
Study publicly available on registry
December 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedResults Posted
Study results publicly available
July 9, 2009
CompletedAugust 31, 2011
June 1, 2011
1.1 years
December 8, 2005
May 18, 2009
August 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
over the first week of treatment
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
over the four weeks of treatment
Mean Pruritus Severity Score Over the Four Weeks of Treatment
over the four weeks of treatment
Mean Score for Pruritus Duration Over the First Week of Treatment
over the first week of treatment
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
over the four weeks of treatment
Study Arms (2)
Levocetirizine
EXPERIMENTALLevocetirizine, once daily, 4 week duration
Desloratadine
ACTIVE COMPARATORDesloratadine, once daily, 4 week duration
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- Any condition that would interfere with the evaluation of the therapeutic response.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (80)
Unknown Facility
Bruges, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Merksem, Belgium
Unknown Facility
Sint-Niklaas, Belgium
Unknown Facility
Woluwe-St-Lamb, Belgium
Unknown Facility
Bernay, France
Unknown Facility
Besançon, France
Unknown Facility
Hyères, France
Unknown Facility
Les Milles, France
Unknown Facility
Marseille, France
Unknown Facility
Montpellier, France
Unknown Facility
Nancy, France
Unknown Facility
Nantes, France
Unknown Facility
Nice, France
Unknown Facility
Nîmes, France
Unknown Facility
Paris, France
Unknown Facility
Poitiers, France
Unknown Facility
Quimper, France
Unknown Facility
Saint-Mandé, France
Unknown Facility
Troyes, France
Unknown Facility
Valence, France
Unknown Facility
Villejuif, France
Unknown Facility
Augsburg, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Düsseldorf, Germany
Unknown Facility
Erlangen, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Mahlow, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
München, Germany
Unknown Facility
Viersen, Germany
Unknown Facility
Caserta, Italy
Unknown Facility
Catania, Italy
Unknown Facility
Cesena, Italy
Unknown Facility
Genova, Italy
Unknown Facility
Modena, Italy
Unknown Facility
Palermo, Italy
Unknown Facility
Pavia, Italy
Unknown Facility
Roma, Italy
Unknown Facility
Siena, Italy
Unknown Facility
Udine, Italy
Unknown Facility
Verona, Italy
Unknown Facility
Johor Bharu, Malaysia
Unknown Facility
Kelantan, Malaysia
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Negeri Sembilan, Malaysia
Unknown Facility
Perak, Malaysia
Unknown Facility
Pulau Pinang, Malaysia
Unknown Facility
Sarawak, Malaysia
Unknown Facility
Brasov, Romania
Unknown Facility
Bucharest, Romania
Unknown Facility
Dolj, Romania
Unknown Facility
Sibiu, Romania
Unknown Facility
Cape Town, South Africa
Unknown Facility
Durban, South Africa
Unknown Facility
Lenasia, South Africa
Unknown Facility
A Coruña, Spain
Unknown Facility
Albacete, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Granada, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Málaga, Spain
Unknown Facility
Murcia (El Palmar), Spain
Unknown Facility
Oviedo, Spain
Unknown Facility
Santiago de Compostela, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Amersham, United Kingdom
Unknown Facility
Cardiff, United Kingdom
Unknown Facility
Irvine, United Kingdom
Unknown Facility
Leicester, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Nuneaton, United Kingdom
Unknown Facility
Salford, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2005
First Posted
December 12, 2005
Study Start
December 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
August 31, 2011
Results First Posted
July 9, 2009
Record last verified: 2011-06