CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 105 enrolled
Drug / intervention
Intravenous acetaminophen plus oral placebo +2 moredrug
Likely dose
Oral acetaminophen plus IV placebo 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/NCT00564629
NCT00564629Phase 3Completed
CompareCT.gov

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

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

In Brief

A Phase 3 clinical trial evaluating Intravenous acetaminophen plus oral placebo, Oral acetaminophen plus IV placebo, and 1 other intervention for Fever. Completed, enrolled 105 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFever
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 28, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.6 years ago

Interventions

Intravenous acetaminophen plus oral placebodrug

Single dose of 1 gm IV acetaminophen

Oral acetaminophen plus IV placebodrug

Single dose of 1 g PO APAP

Reference standard endotoxin (RSE)biological

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.