At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 60 enrolled

Drug / intervention

IV Placebo +2 moredrug

Likely dose

IV Acetaminophen 1 gfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00493311

NCT00493311Phase 3Completed

Compare CT.gov

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

Mallinckrodt·interventional·Posted Jun 28, 2007·Updated Oct 19, 2016

In Brief

A Phase 3 clinical trial evaluating IV Placebo, IV Acetaminophen, and 1 other intervention for Fever. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFever

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2007

First PostedJun 2007

Primary CompletionOct 2007

TodayJul 2026

First PostedJun 28, 2007

Enrollment StartJun 1, 2007

Primary CompletionOct 1, 2007

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 19.0 years ago

Interventions

IV Placebodrug

IV Placebo

IV Acetaminophendrug

Intravenous acetaminophen solution 1 g / 100 ml

Reference Standard Endotoxin (RSE)biological

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.