Acute Pain, PostoperativePhase 4NCT02746263
Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain
A Phase 4 study testing IV acetaminophen, Oral acetaminophen and Morphine in people with Acute Pain, Postoperative, run by Mallinckrodt at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Acute Pain, Postoperative
- What is being tested?
- IV acetaminophen, Oral acetaminophen and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2016to 5 May 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subject must be male or females, between 50 and 90 years of age (inclusive) at Screening.
- Subject must have a weight range of 50 to 120 kg.
- Subject must be in a American Society of Anesthesiologists risk class of I, II, or III.
- 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.
- Female subjects of child-bearing potential must have a negative serum pregnancy test at the Screening and day-of-surgery.
- Subjects must be able to communicate effectively with study personnel.
- Subject must be able and willing to follow all protocol requirements, including operating a PCA device, and study restrictions.
Who cannot join
- 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.
- Subject has an oxygen saturation of less than 95% while awake on room air.
- Subject has a positive test result for human immunodeficiency virus, hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
- 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.
- 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.
- Subject has intra- or postoperative complications, which in the view of the investigator, makes the subject unsuitable for the participation of the study.
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- Subject has received neuraxial (spinal or epidural) opioid injected perioperatively.
- Subject has received a local anesthetic, regional, or wound injection or continuous infusion by any route.
- 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.
- Subject has renal dysfunction or is at risk for renal failure due to volume depletion.
- 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 had any major surgery within 3 months prior to day-of-surgery.
- Subject has a history of acute illness within 14 days prior to day-of-surgery.
- 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.
- 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.
- Subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210
Pensacola Research Consultants
Pensacola, Florida, 32503
About this study
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
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.
- Conditions
- Acute Pain, Postoperative
- Being tested
- IV acetaminophen, Oral acetaminophen, Morphine
- Keywords
- Elective total knee arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV acetaminophenDrug
Also called Ofirmev
Oral acetaminophenDrug
Also called Acetaminophen (APAP)
MorphineDrug
Patient controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| IV acetaminophen/Morphine | Experimental | IV acetaminophen 1000 mg every 6 hours over 18 hours Receives: Drug: IV acetaminophen; Drug: Morphine |
| Oral acetaminophen/Morphine | Active comparator | Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours Receives: Drug: Oral acetaminophen; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity on a Numerical Pain Scale (NPS) for 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.
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start27 Apr 2016
- Primary completion5 May 2016
- Study completion5 May 2016
Why it stopped: Business decision because enrollment was slower than expected
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.
- Other trials for Acute Pain, PostoperativeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746263
- Sponsor's protocol ID
- MNK14504054
- Status last verified
- Nov 2016
- First submitted
- 18 Mar 2016
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02746263
- Acronym / sponsor ID
- MNK14504054
- Conditions
- Acute Pain, Postoperative
- Keywords
- Elective total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision because enrollment was slower than expected
- Enrolment
- 1 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV acetaminophen/Morphine | Experimental | Drug: IV acetaminophen, Drug: MorphineIV acetaminophen 1000 mg every 6 hours over 18 hours |
| Oral acetaminophen/Morphine | Active comparator | Drug: Oral acetaminophen, Drug: MorphineOral acetaminophen two 500 mg tablets every 6 hours over 18 hours |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Subject must be male or females, between 50 and 90 years of age (inclusive) at Screening.
- Subject must have a weight range of 50 to 120 kg.
- Subject must be in a American Society of Anesthesiologists risk class of I, II, or III.
- 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.
Key exclusion criteria (17 listed)
- 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.
- Subject has an oxygen saturation of less than 95% while awake on room air.
- Subject has a positive test result for human immunodeficiency virus, hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
- 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.
- 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.
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 |
|---|---|---|
| IV acetaminophenAlso: Ofirmev | Drug | IV acetaminophen/Morphine |
| Oral acetaminophenAlso: Acetaminophen (APAP) | Drug | Oral acetaminophen/Morphine |
| MorphinePatient controlled analgesia | Drug | IV acetaminophen/Morphine, Oral acetaminophen/Morphine |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Medical Affairs study director
Mallinckrodt
2 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 IV acetaminophen, Oral acetaminophen and Morphine in people with Acute Pain, Postoperative, run by Mallinckrodt at 2 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 6 Nov 2019). 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?
Pain Intensity on a Numerical Pain Scale (NPS) for 18 Hours (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019.