Ignite Creation Date:
2025-12-17 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 2:36 AM
Study NCT ID:
NCT00762567
Status:
COMPLETED
Last Update Posted:
2011-10-06
First Post:
2008-09-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phenylephrine Pediatric Pharmacokinetic Study
Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Organization:
Study Overview
Official Title:
An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2011-10
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:
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to \<12 years, and adolescents, ages 12 to \<18 years.
Detailed Description:
This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. At least twenty-four (24) children, ages 2 to \<12 years, and twelve (12) adolescents, ages 12 to \<18 years, with nasal symptoms due to hay fever or other upper respiratory allergies will complete the study. To ensure that younger children are represented, at least 35% (8) of the 24 children enrolled will range from 2 to \<6 years of age.
Study Oversight
Has Oversight DMC:
False
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?: