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A Study to Evaluate the Drug-Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen

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ClinicalTrials.gov Identifier: NCT02848729
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
This study is to test the hypothesis that an opioid used to treat postsurgical pain, IV morphine, will impact the absorption of coadministered oral acetaminophen and result in altered pharmacokinetics in healthy subjects.

Condition or disease Intervention/treatment Phase
Pain Drug: Acetaminophen (APAP) tablets Drug: IV acetaminophen (APAP) Drug: IV morphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral acetaminophen
Four doses of 1,000 mg oral APAP (2 tablets, 500 mg/tablet), Q6h, Dose 2 and 3 are co-administered with IV morphine
Drug: Acetaminophen (APAP) tablets
Drug: IV morphine
Experimental: IV acetaminophen
Four doses of IV APAP (1000 mg/100 mL), Q6h, Dose 2 and 3 are co-administered with IV morphine
Drug: IV acetaminophen (APAP)
Drug: IV morphine



Primary Outcome Measures :
  1. Area Under the plasma concentration-time curve (AUC) of oral acetaminophen [ Time Frame: Hour -6 to 0, Hour 0 to 6, Hour 12 to 18 ]
    To evaluate the effect of co-administered morphine on acetaminophen's pharmacokinetics before, during, and after co-administration.

  2. Maximum observed plasma concentration (Cmax) of oral acetaminophen [ Time Frame: Hour -6 to 0, Hour 0 to 6, Hour 12 to 18 ]
    To evaluate the effect of co-administered morphine on acetaminophen's pharmacokinetics before, during, and after co-administration.

  3. Time to achieve the maximum observed plasma concentration (Tmax) of oral acetaminophen [ Time Frame: Hour -6 to 0, Hour 0 to 6, Hour 12 to 18 ]
    To evaluate the effect of co-administered morphine on acetaminophen's pharmacokinetics before, during, and after co-administration.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

  1. Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at screening.
  2. 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.
  3. Subject has an oxygen saturation of less than 95% while awake at screening and check-in.
  4. 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.
  5. 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.
  6. Subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02848729     History of Changes
Other Study ID Numbers: MNK14564059
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics