Back to resultsReduction in Pain Intensity Following IV or Oral Pain-relieving Products
Primary Purpose
Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen (Treatment A)
Oral Acetaminophen (Treatment B)
Placebo (Treatment C)
Morphine (Treatment D)
Sponsored by
About this trial
This is an interventional other trial for Pain focused on measuring comparison
Eligibility Criteria
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.
Sites / Locations
- Pharmaceuticals Research Associates, Inc. (PRA)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
IV Acetaminophen
Oral Acetaminophen
Placebo
Morphine
Arm Description
All participants receive IV acetaminophen as one of 4 interventions in random sequence
All participants receive oral acetaminophen as one of 4 interventions in random sequence
All participants receive placebo as one of 4 interventions in random sequence
All participants receive morphine as one of 4 interventions in random sequence
Outcomes
Primary Outcome Measures
Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
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
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02678416
Brief Title
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
June 13, 2016 (Actual)
Study Completion Date
June 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
comparison
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Acetaminophen
Arm Type
Experimental
Arm Description
All participants receive IV acetaminophen as one of 4 interventions in random sequence
Arm Title
Oral Acetaminophen
Arm Type
Experimental
Arm Description
All participants receive oral acetaminophen as one of 4 interventions in random sequence
Arm Title
Placebo
Arm Type
Experimental
Arm Description
All participants receive placebo as one of 4 interventions in random sequence
Arm Title
Morphine
Arm Type
Experimental
Arm Description
All participants receive morphine as one of 4 interventions in random sequence
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen (Treatment A)
Other Intervention Name(s)
OFIRMEV
Intervention Description
Acetaminophen administered by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Oral Acetaminophen (Treatment B)
Other Intervention Name(s)
Acetaminophen tablets
Intervention Description
Acetaminophen administered by oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo (Treatment C)
Other Intervention Name(s)
IV Placebo, Placebo tablets
Intervention Description
Placebo administered by IV infusion or oral tablets
Intervention Type
Other
Intervention Name(s)
Morphine (Treatment D)
Other Intervention Name(s)
IV Morphine
Intervention Description
Morphine administered by IV infusion
Primary Outcome Measure Information:
Title
Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
Description
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).
Time Frame
within 6 hours
Secondary Outcome Measure Information:
Title
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
Description
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
Time Frame
within 6 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Pharmaceuticals Research Associates, Inc. (PRA)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
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