CUTE (Chronic Urticaria Treatment Evaluation)

UCB

Status and phase: Completed; Phase 4

Conditions: Chronic Idiopathic Urticaria

Treatments: Drug: Desloratadine; Drug: Levocetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264303

A00394

EudraCT 2005-000358-65

CUTE

Details and patient eligibility

About

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

Enrollment: 886 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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886 participants in 2 patient groups

Levocetirizine

Experimental group

Description:

Levocetirizine, once daily, 4 week duration

Treatment:

Drug: Levocetirizine

Desloratadine

Active Comparator group

Description:

Desloratadine, once daily, 4 week duration

Treatment:

Drug: Desloratadine