A Study Comparing Reduction in Pain Intensity Following IV or Oral Acetaminophen
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain, Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/14/2017 |
| Start Date: | November 2015 |
| End Date: | August 2016 |
A Randomized, Placebo-Controlled, Double-Blind, Two-Part, Cross-over Study to Compare the Reduction in Pain Intensity After Single-Dose Administration of IV or Oral Acetaminophen and IV Morphine by Using UVB or IDC Pain Models
Compare reduction in pain intensity provided by IV or oral acetaminophen using UVB pain model
Inclusion Criteria
1. Subject 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. Subject must be male, Caucasian, between 18 and 55 years of age (inclusive) at the
time of the screening.
3. Subject 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.
We found this trial at
1
site
Salt Lake City, Utah 84106
Principal Investigator: Shawn L Searle, MD
Phone: 801-269-8200
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