PainPhase 4NCT02848729

Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen

A Phase 4 study testing Oral Acetaminophen, IV Acetaminophen and IV Morphine in people with Pain, run by Mallinckrodt at 3 sites 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

Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this. The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug [pharmacokinetics (PK)]. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Oral Acetaminophen, IV Acetaminophen and IV Morphine
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: 50 participants
Where: 3 sitesUnited States
Study dates: Feb 2016to Mar 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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject 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.
Subject must have a body mass index ≥ 19.0 and ≤ 32.0 kg/m² with a minimum weight of 110 pounds (50 kg) at Screening.

Who cannot join

Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at screening.
Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine/opioids or to any of the excipients in the IV or oral formulations used.
Subject has an oxygen saturation of less than 95% while awake at screening and check-in.
Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine) or alcohol at the screening and check-in.
Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days prior to dosing.
Subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

The University of Rhode Island College of Pharmacy
Kingston, Rhode Island, 02881
NEMA Research, Inc.
Naples, Florida, 34108
University of Arizona College of Pharmacy
Tucson, Arizona, 85718

Other trials in United States

About this study

Official title: A Randomized, 2-Way, Parallel, Single-Blind Pharmacokinetic Study to Evaluate the Interaction Between Intravenous Morphine and Orally or Intravenously Administered Acetaminophen in Healthy Subjects

Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this.

The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug [pharmacokinetics (PK)].

Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers.

IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.

Read the detailed description

Acetaminophen can significantly reduce the use of opioid analgesics when both are used concomitantly for treating moderate to severe pain. The use of IV acetaminophen used concomitantly with opioids has increased in practice for postsurgical pain relief over orally administered acetaminophen because it provides an immediate peak plasma concentration and is believed to provide a faster analgesic effect. Opioids used to treat pain inhibit gastrointestinal motility, including delaying gastric emptying. In patients receiving opioids the absorption of orally administered acetaminophen may be delayed and could result in gastric accumulation of acetaminophen thereby markedly changing the pharmacokinetic profile. The opioid-induced inhibition of gastrointestinal motility would not be expected to affect IV acetaminophen pharmacokinetics. Thus coadministered IV acetaminophen with opioid would yield better outcome in efficacy and reduced risk of side effects comparing with coadministration of oral acetaminophen and opioids.

Conditions: Pain
Being tested: Oral Acetaminophen, IV Acetaminophen, IV Morphine, Placebo Tablets, Saline
Keywords: Post-surgical pain, Pharmacokinetics
Medical subject headings: Pain, Pain, Postoperative

What participants receive

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

Oral AcetaminophenDrug
Also called APAP Oral
Acetaminophen for oral administration (2 tablets, 500 mg/tablet)
IV AcetaminophenDrug
Also called APAP IV
Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL)
IV MorphineDrug
Morphine for IV administration (0.125 mg/kg)
Placebo TabletsDrug
Placebo tablets matching oral acetaminophen
SalineDrug
Saline placebo matching IV acetaminophen

Study groups in NCT02848729
Study group	Role	What they receive
Treatment A: Oral Acetaminophen	Experimental	Treatment A = 4 repeat doses of 1,000 mg oral acetaminophen (2 x 500 mg tablets) and an IV infusion of saline every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of intravenous (IV) morphine (0.125 mg/kg) at Hours 0 and 6 Receives: Drug: Oral Acetaminophen; Drug: IV Morphine; Drug: Saline
Treatment B: IV Acetaminophen	Experimental	Treatment B = 4 repeat doses of IV acetaminophen (1,000 mg/100 mL) and 2 placebo tablets every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6. Receives: Drug: IV Acetaminophen; Drug: IV Morphine; Drug: Placebo Tablets

What is being measured

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

Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen
The area under the plasma drug concentration-time curve (AUC) is an estimate of how much drug remains available for the body to use, within a certain amount of time after the drug is administered. AUC6 is reported for each of the 6-hour dosing periods of acetaminophen before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration
Measured: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration
Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration
AUC18 is reported for the 18-hour treatment period after first morphine co-administration, for each route of acetaminophen administration
Measured: hours 0-18 during treatment with each mode of acetaminophen administration
Maximum Concentration (Cmax) of Acetaminophen
Following the administration of drugs, the plasma concentration generally reaches a single, well-defined peak which is the most drug that is available for the body to use (Cmax). Cmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12), and after (hours 12-18) morphine co-administration for each route of acetaminophen administration.
Measured: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration
Time to Maximum Concentration (Tmax) of Acetaminophen
Following the administration of drugs, the time at which the plasma concentration reaches Cmax is called Tmax. Tmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration.
Measured: hours -6 to 0, 0-6, 6-12 and 12-18 during treatment with each mode of acetaminophen administration

Timeline

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

Feb 2016Mar 2016

First posted28 Jul 2016 (estimated)
Study startFeb 2016
Primary completionMar 2016
Study completionMar 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.
Publications (1)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02848729
Sponsor's protocol ID: MNK14564059
Status last verified: Jan 2020
First submitted: 26 Jul 2016
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Raffa RB, Pawasauskas J, Pergolizzi JV Jr, Lu L, Chen Y, Wu S, Jarrett B, Fain R, Hill L, Devarakonda K. Pharmacokinetics of Oral and Intravenous Paracetamol (Acetaminophen) When Co-Administered with Intravenous Morphine in Healthy Adult Subjects. Clin Drug Investig. 2018 Mar;38(3):259-268. doi: 10.1007/s40261-017-0610-4.
PubMed 29214506

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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All Pain trials

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, 2-Way, Parallel, Single-Blind Pharmacokinetic Study to Evaluate the Interaction Between Intravenous Morphine and Orally or Intravenously Administered Acetaminophen in Healthy Subjects
ClinicalTrials.gov ID: NCT02848729
Acronym / sponsor ID: MNK14564059
Conditions: Pain
Keywords: Post-surgical pain, Pharmacokinetics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Feb 2016 (actual)
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 28 Jul 2016 (estimated)
Results: Posted 29 Jan 2020

Clinical summary

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

Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this.

The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug [pharmacokinetics (PK)].

Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers.

IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Treatment A: Oral Acetaminophen	Experimental	Drug: Oral Acetaminophen, Drug: IV Morphine, Drug: SalineTreatment A = 4 repeat doses of 1,000 mg oral acetaminophen (2 x 500 mg tablets) and an IV infusion of saline every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of intravenous (IV) morphine (0.125 mg/kg) at Hours 0 and 6
Treatment B: IV Acetaminophen	Experimental	Drug: IV Acetaminophen, Drug: IV Morphine, Drug: Placebo TabletsTreatment B = 4 repeat doses of IV acetaminophen (1,000 mg/100 mL) and 2 placebo tablets every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.

Who may qualify

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

Key inclusion criteria (2 listed)

Subject 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.
Subject must have a body mass index ≥ 19.0 and ≤ 32.0 kg/m² with a minimum weight of 110 pounds (50 kg) at Screening.

Key exclusion criteria (6 listed)

Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at screening.
Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine/opioids or to any of the excipients in the IV or oral formulations used.
Subject has an oxygen saturation of less than 95% while awake at screening and check-in.
Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine) or alcohol at the screening and check-in.
Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days prior to dosing.

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
Oral AcetaminophenAlso: APAP OralAcetaminophen for oral administration (2 tablets, 500 mg/tablet)	Drug	Treatment A: Oral Acetaminophen
IV AcetaminophenAlso: APAP IVAcetaminophen for intravenous (IV) administration (1,000 mg/100 mL)	Drug	Treatment B: IV Acetaminophen
IV MorphineMorphine for IV administration (0.125 mg/kg)	Drug	Treatment A: Oral Acetaminophen, Treatment B: IV Acetaminophen
Placebo TabletsPlacebo tablets matching oral acetaminophen	Drug	Treatment B: IV Acetaminophen
SalineSaline placebo matching IV acetaminophen	Drug	Treatment A: Oral Acetaminophen

Primary outcome

Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen
Time frame: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration
The area under the plasma drug concentration-time curve (AUC) is an estimate of how much drug remains available for the body to use, within a certain amount of time after the drug is administered. AUC6 is reported for each of the 6-hour dosing periods of acetaminophen before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration
Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration
Time frame: hours 0-18 during treatment with each mode of acetaminophen administration
AUC18 is reported for the 18-hour treatment period after first morphine co-administration, for each route of acetaminophen administration
Maximum Concentration (Cmax) of Acetaminophen
Time frame: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration
Following the administration of drugs, the plasma concentration generally reaches a single, well-defined peak which is the most drug that is available for the body to use (Cmax). Cmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12), and after (hours 12-18) morphine co-administration for each route of acetaminophen administration.
Time to Maximum Concentration (Tmax) of Acetaminophen
Time frame: hours -6 to 0, 0-6, 6-12 and 12-18 during treatment with each mode of acetaminophen administration
Following the administration of drugs, the time at which the plasma concentration reaches Cmax is called Tmax. Tmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration.

Results and safety

Results posted to the registry on 29 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Acetaminophen	27	11
IV Acetaminophen	23	12

Primary outcome: Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen

Time frame: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration. Mean (Standard Deviation). Unit: hour*microgram per milliliter (h*mcg/mL)

Measure	First Dose - Before Morphine Co-administration n = 11	Second Dose - During Morphine Co-administration n = 11	Third Dose - During Morphine Co-administration n = 11	Fourth Dose - After Morphine Co-administration n = 11
Treatment A: Oral Acetaminophen	31.00 (5.11)	28.51 (5.96)	25.31 (11.59)	52.38 (13.48)
Treatment B: IV Acetaminophen	42.56 (3.94)	44.37 (4.46)	43.59 (4.21)	49.05 (3.95)

Population analysed: Per-protocol population, which is defined as the participants who received all study medication, provided all 33 blood samples within required time points and completed the study with no major protocol deviations.

Primary outcome: Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration

Time frame: hours 0-18 during treatment with each mode of acetaminophen administration. Mean (Standard Deviation). Unit: hour*microgram per milliliter (h*mcg/mL)

Measure	After First Dose of Morphine Co-administration n = 11
Treatment A: Oral Acetaminophen	82.50 (23.28)
Treatment B: IV Acetaminophen	63.58 (6.74)

Primary outcome: Maximum Concentration (Cmax) of Acetaminophen

Time frame: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration. Mean (Standard Deviation). Unit: mcg/mL

Measure	First Dose - Before Morphine Co-administration n = 11	Second Dose - During Morphine Co-administration n = 11	Third Dose - During Morphine Co-administration n = 11	Fourth Dose - After Morphine Co-administration n = 11
Treatment A: Oral Acetaminophen	11.6 (4.11)	7.29 (1.82)	7.25 (3.95)	13.5 (3.31)
Treatment B: IV Acetaminophen	22.6 (3.83)	17.0 (1.48)	17.5 (1.93)	28.5 (4.31)

Population analysed: Per-protocol population

Primary outcome: Time to Maximum Concentration (Tmax) of Acetaminophen

Time frame: hours -6 to 0, 0-6, 6-12 and 12-18 during treatment with each mode of acetaminophen administration. Mean (Full Range). Unit: hours

Measure	First Dose - Before Morphine Co-administration n = 11	Second Dose - During Morphine Co-administration n = 11	Third Dose - During Morphine Co-administration n = 11	Fourth Dose - After Morphine Co-administration n = 11
Oral Acetaminophen	1.48 (0.75 to 2.02)	1.64 (0.50 to 3.00)	3.26 (0.50 to 5.85)	2.84 (1.17 to 4.02)
IV Acetaminophen	0.25 (0.25 to 0.27)	0.50 (0.50 to 0.50)	0.51 (0.50 to 0.57)	0.25 (0.25 to 0.28)

Population analysed: Per-protocol population

Adverse events

Time frame: From start of the study to the end of study (approximately 2 weeks, including wash-out period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Acetaminophen	0 of 27 (0%)	22 of 27 (81.5%)	0 of 27
IV Acetaminophen	0 of 23 (0%)	17 of 23 (73.9%)	0 of 23

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.
Derived from this study: PubMed 29214506Raffa RB, Pawasauskas J, Pergolizzi JV Jr, Lu L, Chen Y, Wu S, Jarrett B, Fain R, Hill L, Devarakonda K. Pharmacokinetics of Oral and Intravenous Paracetamol (Acetaminophen) When Co-Administered with Intravenous Morphine in Healthy Adult Subjects. Clin Drug Investig. 2018 Mar;38(3):259-268. doi: 10.1007/s40261-017-0610-4.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral Acetaminophen, IV Acetaminophen and IV Morphine in people with Pain, run by Mallinckrodt at 3 sites 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 2 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 3 sites 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 29 Jan 2020). 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?

Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen (time frame: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration). The study lists 4 primary outcomes in all. 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 NCT02848729, which also lists 1 linked publication.

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.