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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678416
Recruitment Status : Completed
First Posted : February 9, 2016
Results First Posted : December 20, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Drug: IV Acetaminophen (Treatment A) Drug: Oral Acetaminophen (Treatment B) Drug: Placebo (Treatment C) Other: Morphine (Treatment D) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official 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
Actual Study Start Date : December 7, 2015
Actual Primary Completion Date : June 13, 2016
Actual Study Completion Date : June 13, 2016


Arm Intervention/treatment
Experimental: IV Acetaminophen
All participants receive IV acetaminophen as one of 4 interventions in random sequence
Drug: IV Acetaminophen (Treatment A)
Acetaminophen administered by intravenous (IV) infusion
Other Name: OFIRMEV

Drug: Placebo (Treatment C)
Placebo administered by IV infusion or oral tablets
Other Names:
  • IV Placebo
  • Placebo tablets

Experimental: Oral Acetaminophen
All participants receive oral acetaminophen as one of 4 interventions in random sequence
Drug: Oral Acetaminophen (Treatment B)
Acetaminophen administered by oral tablets
Other Name: Acetaminophen tablets

Drug: Placebo (Treatment C)
Placebo administered by IV infusion or oral tablets
Other Names:
  • IV Placebo
  • Placebo tablets

Experimental: Placebo
All participants receive placebo as one of 4 interventions in random sequence
Drug: Placebo (Treatment C)
Placebo administered by IV infusion or oral tablets
Other Names:
  • IV Placebo
  • Placebo tablets

Experimental: Morphine
All participants receive morphine as one of 4 interventions in random sequence
Drug: Placebo (Treatment C)
Placebo administered by IV infusion or oral tablets
Other Names:
  • IV Placebo
  • Placebo tablets

Other: Morphine (Treatment D)
Morphine administered by IV infusion
Other Name: IV Morphine




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. 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.
  2. Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the screening.
  3. 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

  1. A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
  2. 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.
  3. A positive test result for drugs of abuse, alcohol, or cotinine.
  4. Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.
  5. A history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
  6. Any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678416


Locations
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United States, Utah
Pharmaceuticals Research Associates, Inc. (PRA)
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02678416    
Other Study ID Numbers: MNK14504055
First Posted: February 9, 2016    Key Record Dates
Results First Posted: December 20, 2019
Last Update Posted: February 5, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mallinckrodt:
comparison
Additional relevant MeSH terms:
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Pain
Neurologic Manifestations
Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics