Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT00598559
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
Sponsor:
Mallinckrodt
Organization:
Study Overview
Official Title:
A Phase III, Multi-Center, Open-Label, Prospective, Repeated Dose, Randomized, Controlled, Multi-Day Study of the Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients
Status:
COMPLETED
Status Verified Date:
2016-09
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 study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.
Detailed Description:
• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients
Secondary Objectives:
* To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment
* To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment
* To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment
* To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment
Secondary Objectives:
* To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment
* To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment
* To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment
* To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment
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?: