Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 7:21 PM
Study NCT ID:
NCT01744106
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Sponsor:
Perrigo Company
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Status:
COMPLETED
Status Verified Date:
2016-04
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:
This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in children for the temporary relief of nasal congestion due to the common cold, an indication described under 21 CFR 341.80(b)(1).
Detailed Description:
None
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?: