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

NCT02678416 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MNK14504055
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

comparison

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area

  within 6 hours

Study Arms (4)

IV Acetaminophen

EXPERIMENTAL

All participants receive IV acetaminophen as one of 4 interventions in random sequence

Drug: IV Acetaminophen (Treatment A); Drug: Placebo (Treatment C)

Oral Acetaminophen

EXPERIMENTAL

All participants receive oral acetaminophen as one of 4 interventions in random sequence

Drug: Oral Acetaminophen (Treatment B); Drug: Placebo (Treatment C)

Placebo

EXPERIMENTAL

All participants receive placebo as one of 4 interventions in random sequence

Drug: Placebo (Treatment C)

Morphine

EXPERIMENTAL

All participants receive morphine as one of 4 interventions in random sequence

Drug: Placebo (Treatment C); Other: Morphine (Treatment D)

Interventions

IV Acetaminophen (Treatment A) DRUG

Acetaminophen administered by intravenous (IV) infusion

Also known as: OFIRMEV

IV Acetaminophen

Oral Acetaminophen (Treatment B) DRUG

Acetaminophen administered by oral tablets

Also known as: Acetaminophen tablets

Oral Acetaminophen

Placebo (Treatment C) DRUG

Placebo administered by IV infusion or oral tablets

Also known as: IV Placebo, Placebo tablets

IV Acetaminophen; Morphine; Oral Acetaminophen; Placebo

Morphine (Treatment D) OTHER

Morphine administered by IV infusion

Also known as: IV Morphine

Morphine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
• 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.
• A positive test result for drugs of abuse, alcohol, or cotinine.
• Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.
• A history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (1)

Pharmaceuticals Research Associates, Inc. (PRA)

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: December 7, 2015
• Primary Completion: June 13, 2016
• Study Completion: June 13, 2016
• Last Updated: February 5, 2020
• Results First Posted: December 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)