Ignite Creation Date:
2024-05-05 @ 10:19 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01081574
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2010-03-04
Brief Title:
Pharmacokinetic Study of Bilastine in Children From 2 to 12 Years of Age With Either Allergic Rhinoconjunctivitis AR or Chronic Urticaria CU
Sponsor:
Faes Farma SA
Organization:
Faes Farma SA
Study Overview
Official Title:
A Multicentre International Adaptive Open-label Repeated Administration Pharmacokinetic Study of Bilastine in Children From 2 to 12 Years of Age With Allergic Rhinoconjunctivitis or Chronic Urticaria
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:
The conduct of this clinical trial is aimed at determining the most suitable dose regimen for children in different age groups and secondarily to assess the safety and tolerability of bilastine in this paediatric population subset
Detailed Description:
The objective of this study is to assess the pharmacokinetics of bilastine in children aged 2 to 12 years with allergic rhinoconjunctivitis seasonal allergic rhinitis SAR andor perennial allergic rhinitis PAR or chronic urticaria CU in order to ascertain that the systemic exposure attained with a dose of 10 mgQD or lower is comparable to that achieved in adults and adolescents administered with a dose of 20 mgQD
Additional objectives are to describe the safety and tolerability of a repeated administration of bilastine in children with AR or CU
Additional objectives are to describe the safety and tolerability of a repeated administration of bilastine in children with AR or CU
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 |
|---|---|---|---|
| 2009-012013-22 | EUDRACT_NUMBER | None | None |