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Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain

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ClinicalTrials.gov Identifier: NCT02746263
Recruitment Status : Terminated (Business decision because enrollment was slower than expected)
First Posted : April 21, 2016
Results First Posted : November 6, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total knee replacement.

Condition or disease Intervention/treatment Phase
Acute Pain, Postoperative Drug: IV acetaminophen Drug: Oral acetaminophen Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Repeated Dose, Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain in Combination With Patient-Controlled Analgesia With Morphine in Adults Following Elective Total Knee Arthroplasty
Actual Study Start Date : April 27, 2016
Actual Primary Completion Date : May 5, 2016
Actual Study Completion Date : May 5, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV acetaminophen/Morphine
IV acetaminophen 1000 mg every 6 hours over 18 hours
Drug: IV acetaminophen
Other Name: Ofirmev

Drug: Morphine
Patient controlled analgesia

Active Comparator: Oral acetaminophen/Morphine
Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours
Drug: Oral acetaminophen
Other Name: Acetaminophen (APAP)

Drug: Morphine
Patient controlled analgesia




Primary Outcome Measures :
  1. Pain Intensity on a Numerical Pain Scale (NPS) for 18 Hours [ Time Frame: 18 hours ]
    Participants rate intensity of their pain on a Numerical Pain Scale (NPS) from 0-10, wherein 0=no pain (better) and 10=most intense pain (worse). The highest possible score is 10.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date on the informed consent form.
  2. Subject must be male or females, between 50 and 90 years of age (inclusive) at Screening.
  3. Subject must have a weight range of 50 to 120 kg.
  4. Subject must be in a American Society of Anesthesiologists risk class of I, II, or III.
  5. Subject must have successfully completed an unilateral uncomplicated total knee replacement surgery, able to take oral medication, and report having moderate to severe acute pain as determined by a pain score ≥ 5 from the 11-point Numeric Pain Rating Scale (NPRS) scale during the period of 3 to 6 hours postsurgery.
  6. Female subjects of child-bearing potential must have a negative serum pregnancy test at the Screening and day-of-surgery.
  7. Subjects must be able to communicate effectively with study personnel.
  8. Subject must be able and willing to follow all protocol requirements, including operating a PCA device, and study restrictions.

Exclusion Criteria:

  1. Subject is from a vulnerable population, as defined by the Code of Federal Regulations Title 45, Part 46, 1. Section 46.111(b), including but not limited to employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the Institutional Review Board.
  2. Subject has an oxygen saturation of less than 95% while awake on room air.
  3. Subject has a positive test result for human immunodeficiency virus, hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
  4. Subject has used an average of 30 mg oral morphine equivalents or greater, 1 to 2 weeks prior to the day of surgery. Subjects who, in the investigator's opinion are developing opioid tolerance will be excluded.
  5. Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine or to any of the excipients in the IV or oral formulations used.
  6. Subject has intra- or postoperative complications, which in the view of the investigator, makes the subject unsuitable for the participation of the study.
  7. Subject has received neuraxial (spinal or epidural) opioid injected perioperatively.
  8. Subject has received a local anesthetic, regional, or wound injection or continuous infusion by any route.
  9. Subject has impaired liver function (eg, aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than or equal to 3.0 times the upper limit of normal), active hepatic disease, evidence of clinically significant liver disease, or other condition (eg, alcoholism, cirrhosis, or hepatitis) that suggests the potential for an increased susceptibility to hepatic toxicity with study drug exposure.
  10. Subject has renal dysfunction or is at risk for renal failure due to volume depletion.
  11. 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.
  12. Subject has had any major surgery within 3 months prior to day-of-surgery.
  13. Subject has a history of acute illness within 14 days prior to day-of-surgery.
  14. Subject has participated in another clinical study within 30 days prior to day-of-surgery or plans to participate in another clinical study while concurrently enrolled in this study.
  15. Subject has a history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
  16. Subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.
  17. Subject has a positive test result for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids [including medical use of marijuana], cocaine, methamphetamine, methadone, or methylenedioxy-methamphetamine) at Screening. Subjects with a positive test result for prescribed drugs may be included in the study at the discretion of the investigator. Subjects with a positive test result for cannabinoids with a prescription for medical marijuana will be excluded from the study, subjects with a prescription for dronabinol (∆-9-tetrahydrocannabinol) may be included at the discretion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746263


Locations
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United States, Florida
Pensacola Research Consultants
Pensacola, Florida, United States, 32503
United States, Ohio
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Medical Affairs Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02746263     History of Changes
Other Study ID Numbers: MNK14504054
First Posted: April 21, 2016    Key Record Dates
Results First Posted: November 6, 2019
Last Update Posted: November 19, 2019
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt:
Elective total knee arthroplasty
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics