Overview

This trial is active, not recruiting.

Condition pain
Treatments iv acetaminophen, iv morphine, placebo tablet, acetaminophen tablets, iv placebo
Phase phase 4
Sponsor Mallinckrodt
Start date November 2015
End date June 2016
Trial size 78 participants
Trial identifier NCT02678416, MNK14504055

Summary

Compare reduction in pain intensity provided by IV or oral acetaminophen using UVB pain model

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
Acetaminophen, 100 mL of 1,000 mg/100 mL will be administered IV (15 minute infusion) and 2 placebo tablets will be administered orally
iv acetaminophen Ofirmev
IV formulation
placebo tablet
tablet
(Experimental)
An IV placebo 100 mL (15 minute infusion of saline) and 2 acetaminophen tablets (500 mg/tablet) will be administered orally
acetaminophen tablets
oral formulation
iv placebo
IV formulation
(Placebo Comparator)
An IV placebo 100 mL (15 minute infusion of saline) and 2 placebo tablets will be administered orally
placebo tablet
tablet
iv placebo
IV formulation
(Active Comparator)
An IV morphine (0.1 mg/kg) in 100 mL saline (15 minute infusion of saline) and 2 placebo tablets will be administered orally
iv morphine
IV formulation
placebo tablet
tablet

Primary Outcomes

Measure
Sum of change in pain intensity from baseline in UVB pain model
time frame: 0 to 6 Hours

Secondary Outcomes

Measure
Sum of change in pain threshold from baseline in IDC pain model
time frame: 0 to 4.5 Hours

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Mallinckrodt.