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

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Fever
Interventions
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.

Trial Locations (1)

78705

Scirex Research Center, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY