Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Faes Farma

Status and phase: Completed; Phase 3

Conditions: Urticaria

Treatments: Drug: Levocetirizine; Drug: Placebo; Drug: Bilastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421109

2006-001245-33 (EudraCT Number)

BILA 2006/UCI

Details and patient eligibility

About

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

Full description

A total of 540 patients with CIU will be enrolled in this pivotal, randomised, multicentre, international, double-blind, placebo and active-comparator controlled, parallel study . Patients will be selected from both public and private clinical practices. The study population includes males and females between 18 and 70 years of age, suffering from CIU for at least 6 weeks prior to entry in the study with no identifiable cause.

Enrollment: 522 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 70 years old.
• Documented history of CIU for at least 6 weeks prior to entry in the study.

Exclusion criteria

• Dermatological pathology other than chronic idiopathic urticaria.
• History of autoimmune disorders, Hodgkin's disease, lymphoma, leukemia and generalized cancer.
• Pregnant or breast-feeding women.
• Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
• Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
• Patients who are currently participating in or have participated in another clinical trial within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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522 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Bilastine 20 mg

Treatment:

Drug: Bilastine

2

Active Comparator group

Description:

Levocetirizine 5 mg

Treatment:

Drug: Levocetirizine

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo