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
Overview
- Phase
- Phase 4
- Intervention
- IV Acetaminophen (Treatment A)
- Conditions
- Pain
- Sponsor
- Mallinckrodt
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
IV Acetaminophen
All participants receive IV acetaminophen as one of 4 interventions in random sequence
Intervention: IV Acetaminophen (Treatment A)
IV Acetaminophen
All participants receive IV acetaminophen as one of 4 interventions in random sequence
Intervention: Placebo (Treatment C)
Oral Acetaminophen
All participants receive oral acetaminophen as one of 4 interventions in random sequence
Intervention: Oral Acetaminophen (Treatment B)
Oral Acetaminophen
All participants receive oral acetaminophen as one of 4 interventions in random sequence
Intervention: Placebo (Treatment C)
Placebo
All participants receive placebo as one of 4 interventions in random sequence
Intervention: Placebo (Treatment C)
Morphine
All participants receive morphine as one of 4 interventions in random sequence
Intervention: Placebo (Treatment C)
Morphine
All participants receive morphine as one of 4 interventions in random sequence
Intervention: Morphine (Treatment D)
Outcomes
Primary Outcomes
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
- Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area(within 6 hours)