CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 79 enrolled
Drug / intervention
IV Acetaminophen (Treatment A) +3 moredrug
Likely dose
Not stated in 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/NCT02678416
NCT02678416Phase 4Completed

A Randomized, Placebo-Controlled, Double-Blind, Two-Part, Cross-over Study in Healthy Adult Male Subjects to Compare the Reduction in Pain Intensity After Single-Dose Administration of Intravenous or Oral Acetaminophen and Intravenous Morphine by Using UVB Burn and Intradermal Capsaicin Experimental Pain Models

Mallinckrodt·interventional·Posted Feb 9, 2016·Updated Feb 5, 2020

In Brief

A Phase 4 clinical trial evaluating IV Acetaminophen (Treatment A), Oral Acetaminophen (Treatment B), and 2 other interventions for Pain. Completed, enrolled 79 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity. The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartDec 7, 2015
Primary CompletionJun 13, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.4 years ago

Interventions

IV Acetaminophen (Treatment A)drug

Acetaminophen administered by intravenous (IV) infusion

Oral Acetaminophen (Treatment B)drug

Acetaminophen administered by oral tablets

Placebo (Treatment C)drug

Placebo administered by IV infusion or oral tablets

Morphine (Treatment D)other

Morphine administered by IV infusion