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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: IV Acetaminophen (Treatment A)
* Drug: Oral Acetaminophen (Treatment B)
* Drug: Placebo (Treatment C)
* Other: Morphine (Treatment D)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Acetaminophen<br>All participants receive IV acetaminophen as one of 4 interventions in random sequence | Drug: IV Acetaminophen (Treatment A)<br>* Acetaminophen administered by intravenous (IV) infusion<br>* Other names: OFIRMEV;Drug: Placebo (Treatment C)<br>* Placebo administered by IV infusion or oral tablets<br>* Other names: Placebo tablets;|
| Experimental: Oral Acetaminophen<br>All participants receive oral acetaminophen as one of 4 interventions in random sequence | Drug: Oral Acetaminophen (Treatment B)<br>* Acetaminophen administered by oral tablets<br>* Other names: Acetaminophen tablets;Drug: Placebo (Treatment C)<br>* Placebo administered by IV infusion or oral tablets<br>* Other names: Placebo tablets;|
| Experimental: Placebo<br>All participants receive placebo as one of 4 interventions in random sequence | Drug: Placebo (Treatment C)<br>* Placebo administered by IV infusion or oral tablets<br>* Other names: Placebo tablets;|
| Experimental: Morphine<br>All participants receive morphine as one of 4 interventions in random sequence | Drug: Placebo (Treatment C)<br>* Placebo administered by IV infusion or oral tablets<br>* Other names: Placebo tablets;Other: Morphine (Treatment D)<br>* Morphine administered by IV infusion<br>* Other names: IV Morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | within 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comparison