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Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen

NCT02848729 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-05

Study results available
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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 \[pharmacokinetics (PK)\].

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.

Conditions

Interventions

DRUG

Oral Acetaminophen

Acetaminophen for oral administration (2 tablets, 500 mg/tablet)

DRUG

IV Acetaminophen

Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL)

DRUG

IV Morphine

Morphine for IV administration (0.125 mg/kg)

DRUG

Placebo Tablets

Placebo tablets matching oral acetaminophen

DRUG

Saline

Saline placebo matching IV acetaminophen

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848729 on ClinicalTrials.gov