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

Mallinckrodt

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: IV Acetaminophen (Treatment A); Drug: Placebo (Treatment C); Drug: Oral Acetaminophen (Treatment B); Other: Morphine (Treatment D)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02678416

MNK14504055

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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79 participants in 4 patient groups

IV Acetaminophen

Experimental group

Description:

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

Treatment:

Drug: Placebo (Treatment C)

Drug: IV Acetaminophen (Treatment A)

Oral Acetaminophen

Experimental group

Description:

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

Treatment:

Drug: Oral Acetaminophen (Treatment B)

Drug: Placebo (Treatment C)

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo (Treatment C)

Morphine

Experimental group

Description:

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

Treatment:

Other: Morphine (Treatment D)

Drug: Placebo (Treatment C)