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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678416
• Other study ID #: MNK14504055
• Status: Completed
• Phase: Phase 4
• Start date: December 7, 2015
• Est. completion date: June 13, 2016

Study information

• Verified date: November 2019
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 13, 2016
• Est. primary completion date: June 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

1. 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. Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the screening.

3. 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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• IV Acetaminophen (Treatment A)
Acetaminophen administered by intravenous (IV) infusion
• Oral Acetaminophen (Treatment B)
Acetaminophen administered by oral tablets
• Placebo (Treatment C)
Placebo administered by IV infusion or oral tablets

Other:
• Morphine (Treatment D)
Morphine administered by IV infusion

Locations

Country	Name	City	State
United States	Pharmaceuticals Research Associates, Inc. (PRA)	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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