NCT02678416

Reduction in Pain Intensity Following IV or Oral Pain-relieving Products

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	IV Acetaminophen (Treatment A)	Acetaminophen administered by intravenous (IV) infusion
DRUG	Oral Acetaminophen (Treatment B)	Acetaminophen administered by oral tablets
DRUG	Placebo (Treatment C)	Placebo administered by IV infusion or oral tablets
OTHER	Morphine (Treatment D)	Morphine administered by IV infusion

Timeline

• Start date: 2015-12-07
• Primary completion: 2016-06-13
• Completion: 2016-06-13
• First posted: 2016-02-09
• Last updated: 2020-02-05
• Results posted: 2019-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study