NCT00493311

Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen Versus Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given through a needle into a vein in your arm) is safe and effective in controlling fever when compared to placebo. Acetaminophen given this way is the investigational part of this study.

Detailed description

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen (IVAPAP) Versus Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	IV Placebo	IV Placebo
DRUG	IV Acetaminophen	Intravenous acetaminophen solution 1 g / 100 ml
BIOLOGICAL	Reference Standard Endotoxin (RSE)	Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-06-28
• Last updated: 2016-10-19
• Results posted: 2010-09-21

Locations

1 site across 1 country: United States