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Completed

NCT Number: NCT02678416

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pharmaceuticals Research Associates, Inc. (PRA)

Salt Lake City, Utah, 84106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have a health status of "healthy" assessed by the investigator and defined as no clinically significant deviation from normal medical history, physical examination, vital signs, and clinical laboratory determinations.
  • Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the screening.
  • Must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2 with a minimum weight of 110 pounds (50 kg) at screening.

Exclusion criteria

  • A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
  • A history of any drug allergy, hypersensitivity, or intolerance to acetaminophen, morphine, or capsaicin or to any of the excipients in the IV or oral formulations used.
  • A positive test result for drugs of abuse, alcohol, or cotinine.
  • Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.
  • A history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
  • Any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Treatment and study plan

IV Acetaminophen (Treatment A)

Drug

Acetaminophen administered by intravenous (IV) infusion

Other names: OFIRMEV

Oral Acetaminophen (Treatment B)

Drug

Acetaminophen administered by oral tablets

Other names: Acetaminophen tablets

Placebo (Treatment C)

Drug

Placebo administered by IV infusion or oral tablets

Other names: IV Placebo, Placebo tablets

Morphine (Treatment D)

Other

Morphine administered by IV infusion

Other names: IV Morphine

Primary outcomes

  1. Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model

    Time frame: within 6 hours

    The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).

Secondary outcomes

  1. Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area

    Time frame: within 6 hours

    Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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