Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
Study NCT ID:
NCT00225706
Status:
COMPLETED
Last Update Posted:
2010-04-12
First Post:
2005-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Caldolor in Hospitalized Febrile Pediatric Patients
Sponsor:
Cumberland Pharmaceuticals
Organization:
Study Overview
Official Title:
Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF \[37.0ºC\]).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: