CUTE (Chronic Urticaria Treatment Evaluation)
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Idiopathic Urticaria
Intervention: Levocetirizine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Krassimir Mitchev, Study Director, Affiliation: UCB
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
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Mean pruritus severity score over the first week of treatment
Secondary outcome: Mean CIU composite score over the first and over the four weeks of treatment, mean pruritus severity score over four weeks of treatment, mean score for pruritus duration, number and size of wheals over the first and past over the four weeks of treatment,
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Brussels, Belgium
Woluwe-St-Lamb, Belgium
Liege, Belgium
Valence, France
Troyes, France
Bernay, France
Quimper, France
Paris, France
Nantes, France
Villejuif, France
Les Milles, France
Hyeres, France
Nancy, France
Marseille, France
Poitiers, France
Saint-Mande, France
Nice, France
Dresden, Germany
Leipzig, Germany
Augsburg, Germany
Mahlow, Germany
Viersen, Germany
Koln, Germany
Munchen, Germany
Berlin, Germany
Hamburg, Germany
Hannover, Germany
Dusseldorf, Germany
Mainz, Germany
Gottingen, Germany
Erlangen, Germany
Verona, Italy
Pavia, Italy
Roma, Italy
Siena, Italy
Cesena, Italy
Catania, Italy
Palermo, Italy
Genova, Italy
Modena, Italy
Udine, Italy
Caserta, Italy
Perak, Malaysia
Pulau Pinang, Malaysia
Kuala Lumpur, Malaysia
Sarawak, Malaysia
Johor Bharu, Malaysia
Negeri Sembilan, Malaysia
Kelantan, Malaysia
Bucharest, Romania
Brasov, Romania
Sibiu, Romania
Dolj, Romania
Cape Town, South Africa
Durban, South Africa
Lenasia, South Africa
Barcelona, Spain
Madrid, Spain
Valencia, Spain
Granada, Spain
Malaga, Spain
Coruna, Spain
Oviedo, Spain
Santiago de Compostela, Spain
Albacete, Spain
Sevila, Spain
Valencia, Spain
Murcia (El Palmar), Spain
Cardiff, United Kingdom
Salford, United Kingdom
Amersham, United Kingdom
Irvine, United Kingdom
Nuneaton, United Kingdom
Leicester, United Kingdom
London, United Kingdom
Additional Information
Starting date: December 2005
Ending date: January 2007
Last updated: March 6, 2008
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