PainPhase 4NCT02678416

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

A Phase 4 study testing IV Acetaminophen (Treatment A), Oral Acetaminophen (Treatment B) and Morphine (Treatment D) in people with Pain, run by Mallinckrodt at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: IV Acetaminophen (Treatment A), Oral Acetaminophen (Treatment B) and Morphine (Treatment D)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 1 siteUnited States
Study dates: 7 Dec 2015to 13 Jun 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.
Any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pharmaceuticals Research Associates, Inc. (PRA)
Salt Lake City, Utah, 84106

Other trials in United States

About this study

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

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
Being tested: IV Acetaminophen (Treatment A), Oral Acetaminophen (Treatment B), Placebo (Treatment C), Morphine (Treatment D)
Keywords: comparison
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV Acetaminophen (Treatment A)Drug
Also called OFIRMEV
Acetaminophen administered by intravenous (IV) infusion
Oral Acetaminophen (Treatment B)Drug
Also called Acetaminophen tablets
Acetaminophen administered by oral tablets
Placebo (Treatment C)Drug
Also called IV Placebo, Placebo tablets
Placebo administered by IV infusion or oral tablets
Morphine (Treatment D)Other
Also called IV Morphine
Morphine administered by IV infusion

Study groups in NCT02678416
Study group	Role	What they receive
IV Acetaminophen	Experimental	All participants receive IV acetaminophen as one of 4 interventions in random sequence Receives: 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 Receives: Drug: Oral Acetaminophen (Treatment B); Drug: Placebo (Treatment C)
Placebo	Experimental	All participants receive placebo as one of 4 interventions in random sequence Receives: Drug: Placebo (Treatment C)
Morphine	Experimental	All participants receive morphine as one of 4 interventions in random sequence Receives: Drug: Placebo (Treatment C); Other: Morphine (Treatment D)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: within 6 hours

Secondary outcomes (1)

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
Measured: within 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 201513 Jun 2016

First posted9 Feb 2016 (estimated)
Study start7 Dec 2015
Primary completion13 Jun 2016
Study completion13 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02678416
Sponsor's protocol ID: MNK14504055
Status last verified: Nov 2019
First submitted: 5 Feb 2016
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02678416
Acronym / sponsor ID: MNK14504055
Conditions: Pain
Keywords: comparison
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: 7 Dec 2015 (actual)
Primary completion: 13 Jun 2016 (actual)
Study completion: 13 Jun 2016 (actual)
First posted: 9 Feb 2016 (estimated)
Results: Posted 20 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
IV Acetaminophen	Experimental	Drug: IV Acetaminophen (Treatment A), Drug: Placebo (Treatment C)All participants receive IV acetaminophen as one of 4 interventions in random sequence
Oral Acetaminophen	Experimental	Drug: Oral Acetaminophen (Treatment B), Drug: Placebo (Treatment C)All participants receive oral acetaminophen as one of 4 interventions in random sequence
Placebo	Experimental	Drug: Placebo (Treatment C)All participants receive placebo as one of 4 interventions in random sequence
Morphine	Experimental	Drug: Placebo (Treatment C), Other: Morphine (Treatment D)All participants receive morphine as one of 4 interventions in random sequence

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IV Acetaminophen (Treatment A)Also: OFIRMEVAcetaminophen administered by intravenous (IV) infusion	Drug	IV Acetaminophen
Oral Acetaminophen (Treatment B)Also: Acetaminophen tabletsAcetaminophen administered by oral tablets	Drug	Oral Acetaminophen
Placebo (Treatment C)Also: IV Placebo, Placebo tabletsPlacebo administered by IV infusion or oral tablets	Drug	IV Acetaminophen, Morphine, Oral Acetaminophen, Placebo
Morphine (Treatment D)Also: IV MorphineMorphine administered by IV infusion	Other	Morphine

Primary outcome

Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
Time frame: within 6 hours
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).

1 secondary outcome

Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
Time frame: within 6 hours

Results and safety

Results posted to the registry on 20 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1	12	11

Primary outcome: Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model

Time frame: within 6 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	IV Acetaminophen n = 11	Oral Acetaminophen n = 11	Placebo n = 11	Morphine n = 11
Value	0.73 (1.104)	-0.64 (1.804)	-0.36 (1.567)	0.36 (1.206)

Population analysed: Completers, defined as participants who were enrolled in the study, took the entire dose of all study drugs, and provided all pain intensity assessments.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose up to Day 46. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: IV Acetaminophen	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Part 1: Oral Acetaminophen	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Part 1: Placebo	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part 1: Morphine	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12
Part 2: IV Acetaminophen	0 of 64 (0%)	10 of 64 (15.6%)	0 of 64
Part 2: Oral Acetaminophen	0 of 65 (0%)	12 of 65 (18.5%)	0 of 65
Part 2: Placebo	0 of 65 (0%)	14 of 65 (21.5%)	0 of 65
Part 2: Morphine	0 of 64 (0%)	38 of 66 (57.6%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Mallinckrodt

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IV Acetaminophen (Treatment A), Oral Acetaminophen (Treatment B) and Morphine (Treatment D) in people with Pain, run by Mallinckrodt at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model (time frame: within 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02678416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.