Status:
COMPLETED
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
Lead Sponsor:
Faes Farma, S.A.
Conditions:
Urticaria
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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.
Detailed 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 sel...
Eligibility Criteria
Inclusion
- 18 to 70 years old.
- Documented history of CIU for at least 6 weeks prior to entry in the study.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT00421109
Start Date
July 1 2006
End Date
July 1 2007
Last Update
April 5 2012
Active Locations (50)
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1
Centre nº 101
Buenos Aires, Argentina, 1035
2
Centre nº 105
Buenos Aires, Argentina, 1280
3
Centre nº 104
Buenos Aires, Argentina, 1406
4
Centre nº 103
Buenos Aires, Argentina, 1425