Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421109
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2007-01-09
Brief Title:
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
Sponsor:
Faes Farma SA
Organization:
Faes Farma SA
Study Overview
Official Title:
Double-blind Randomised Placebo-controlled Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg QD compared to Levocetirizine 5 mg QD 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001245-33 | EUDRACT_NUMBER | None | None |