Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01127620
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2010-05-19
Brief Title:
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
Sponsor:
Faes Farma SA
Organization:
Faes Farma SA
Study Overview
Official Title:
A Phase III Comparative Study for the Efficacy and Safety of Bilastine 20 mg Versus Cetirizine 10 mg and Placebo in the Treatment of Perennial Allergic Rhinitis During 4 Weeks Followed by a Long-term Safety Extension With Bilastine 20 mg
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Double-blind phase The objective of the study was to evaluate the efficacy and safety of Bilastine 20 mg compared to Cetirizine and placebo for the treatment of perennial allergic rhinitis
Open-label Phase The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis
Open-label Phase The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis
Detailed Description:
Double-blind randomized placebo-controlled parallel-group international multicenter study followed by an open label extension Duration of the double-blind period was 28 days and the duration of the open label period was 12 additional months
The primary efficacy variable of the double-blind period was the area under curve AUC of total symptoms scale TSS from baseline defined as the mean of 6 last points of the patients diary before randomization to D28 visit according to the patients assessment on reflective symptoms 650 patients were included in the study and 614 completed the double-blind phase Out of the 614 patients who completed the double blind period a total of 513 patients started the open label period with Bilastine 20 mg 836
The primary efficacy variable of the double-blind period was the area under curve AUC of total symptoms scale TSS from baseline defined as the mean of 6 last points of the patients diary before randomization to D28 visit according to the patients assessment on reflective symptoms 650 patients were included in the study and 614 completed the double-blind phase Out of the 614 patients who completed the double blind period a total of 513 patients started the open label period with Bilastine 20 mg 836
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