Clinical trial NCT00264303: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Idiopathic Urticaria
Keywords: Chronic Idiopathic Urticaria
CUTE Levocetirizine Xyzal®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 886
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Mean Pruritus Severity Score Over the First Week of Treatment
timeFrame: over the first week of treatment
Secondary outcomes:
measure: Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
timeFrame: over the first week of treatment
measure: Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
timeFrame: over the four weeks of treatment
measure: Mean Pruritus Severity Score Over the Four Weeks of Treatment
timeFrame: over the four weeks of treatment
measure: Mean Score for Pruritus Duration Over the First Week of Treatment
timeFrame: over the first week of treatment
measure: Mean Score for Pruritus Duration Over the Four Weeks of Treatment
timeFrame: over the four weeks of treatment
Other outcomes:
Locations:
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
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: