NCT00564629

Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever induced by a standard dose of endotoxin

Detailed description

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

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	Intravenous acetaminophen plus oral placebo	Single dose of 1 gm IV acetaminophen
DRUG	Oral acetaminophen plus IV placebo	Single dose of 1 g PO APAP
BIOLOGICAL	Reference standard endotoxin (RSE)	To subjects in both study arms: Administration of a 1 ng/kg body weight test dose of RSE to induce fever and 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: 2007-08-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-11-28
• Last updated: 2016-10-19
• Results posted: 2010-09-21

Locations

1 site across 1 country: United States