Ignite Creation Date:
2024-05-05 @ 10:24 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01108783
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2010-04-21
Brief Title:
A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
Sponsor:
Faes Farma SA
Organization:
Faes Farma SA
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis
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 was to determine the efficacy and tolerability of 20 mg of Bilastine compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis
Detailed Description:
Pivotal double-blind randomized placebo-controlled comparative with desloratadine parallel group international multicenter studyThe Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study A total of 720 patients with seasonal allergic rhinitis were enrolled Duration of treatment was 14 days preceded by one week 7 days of placebo
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