A Study Comparing Reduction in Pain Intensity Following IV or Oral Acetaminophen
This trial is active, not recruiting.
|Treatments||iv acetaminophen, iv morphine, placebo tablet, acetaminophen tablets, iv placebo|
|Start date||November 2015|
|End date||June 2016|
|Trial size||78 participants|
|Trial identifier||NCT02678416, MNK14504055|
Compare reduction in pain intensity provided by IV or oral acetaminophen using UVB pain model
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Sum of change in pain intensity from baseline in UVB pain model
time frame: 0 to 6 Hours
Sum of change in pain threshold from baseline in IDC pain model
time frame: 0 to 4.5 Hours
Male participants from 18 years up to 55 years old.
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.
|Official title||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|
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