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

PHASE3CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Fever
Interventions
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.

Trial Locations (1)

37920

New Orleans Center for Clinical Research-Knoxville, Knoxville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY

NCT00564629 - Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males | Biotech Hunter | Biotech Hunter