Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
Completed · Phase 4 · Has a placebo group
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT02848729
- Run by
- Mallinckrodt
- People needed
- 50
- Starts
- 2016-02-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2020-02-05
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Arizona College of Pharmacy — Tucson, Arizona, United States
- NEMA Research, Inc. — Naples, Florida, United States
- The University of Rhode Island College of Pharmacy — Kingston, Rhode Island, United States
Full record on ClinicalTrials.gov
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