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

NCT02678416 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2020-02-05

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-07
Primary Completion
2016-06-13
Completion
2016-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678416 on ClinicalTrials.gov