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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-07

Study Completion Date

2016-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IV Acetaminophen as an Analgesic Adjunct

NCT02621619

Acute Pain

COMPLETED PHASE4

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

NCT03256487

Pain

UNKNOWN PHASE2

Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects

NCT01924182

Chronic Pain

TERMINATED NA

Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects

NCT02083315

Pain, Acute

COMPLETED PHASE1

Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications

NCT03768011

Pain, Chronic Pain, Joint Pain Syndrome

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IV Acetaminophen

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

Group Type EXPERIMENTAL

IV Acetaminophen (Treatment A)

Intervention Type DRUG

Acetaminophen administered by intravenous (IV) infusion

Placebo (Treatment C)

Intervention Type DRUG

Placebo administered by IV infusion or oral tablets

Oral Acetaminophen

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

Group Type EXPERIMENTAL

Oral Acetaminophen (Treatment B)

Intervention Type DRUG

Acetaminophen administered by oral tablets

Placebo (Treatment C)

Intervention Type DRUG

Placebo administered by IV infusion or oral tablets

Placebo

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

Group Type EXPERIMENTAL

Placebo (Treatment C)

Intervention Type DRUG

Placebo administered by IV infusion or oral tablets

Morphine

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

Group Type EXPERIMENTAL

Placebo (Treatment C)

Intervention Type DRUG

Placebo administered by IV infusion or oral tablets

Morphine (Treatment D)

Intervention Type OTHER

Morphine administered by IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV Acetaminophen (Treatment A)

Acetaminophen administered by intravenous (IV) infusion

Intervention Type DRUG

Oral Acetaminophen (Treatment B)

Acetaminophen administered by oral tablets

Intervention Type DRUG

Placebo (Treatment C)

Placebo administered by IV infusion or oral tablets

Intervention Type DRUG

Morphine (Treatment D)

Morphine administered by IV infusion

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OFIRMEV Acetaminophen tablets IV Placebo Placebo tablets IV Morphine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes