Musculoskeletal PainPhase 4NCT04122443
Acetaminophen (APAP) +/- Oxycodone
A Phase 4 study testing Acetaminophen and Oxycodone in people with Musculoskeletal Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Acetaminophen and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 31 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
- Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
Who cannot join
- Use of an non-steroidal anti-inflammatory drug within the previous six hours
- Use of acetaminophen within the previous six hours
- Use of an opioid within the previous ten days
- Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
- Gout
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
- Conditions
- Musculoskeletal Pain
- Being tested
- Acetaminophen, Oxycodone
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Acetaminophen 650mg
OxycodoneDrug
Oxycodone 10mg
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | Acetaminophen alone Receives: Drug: Acetaminophen |
| Oxycodone/ acetaminophen | Active comparator | Oxycodone + acetaminophen Receives: Drug: Acetaminophen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Assessment
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Measured: 2 hours following treatment
Secondary outcomes (4)
Sustained Pain Relief
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.
Measured: Up to 48 hours following medication administration
Adequacy of Analgesia
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.
Measured: 2 hours following treatment
Satisfaction With Medication
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"
Measured: 2 hours following treatment
Medication-related Adverse Events
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.
Measured: 2 hours following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Dec 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
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 Musculoskeletal PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122443
- Sponsor's protocol ID
- 2019-10592
- Other IDs
- 2019
- Status last verified
- Feb 2024
- First submitted
- 8 Oct 2019
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
- ClinicalTrials.gov ID
- NCT04122443
- Acronym / sponsor ID
- 2019-10592
- Conditions
- Musculoskeletal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen alone |
| Oxycodone/ acetaminophen | Active comparator | Drug: Acetaminophen, Drug: OxycodoneOxycodone + acetaminophen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
- Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
Key exclusion criteria (5 listed)
- Use of an non-steroidal anti-inflammatory drug within the previous six hours
- Use of acetaminophen within the previous six hours
- Use of an opioid within the previous ten days
- Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
- Gout
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 |
|---|---|---|
| AcetaminophenAcetaminophen 650mg | Drug | Acetaminophen, Oxycodone/ acetaminophen |
| OxycodoneOxycodone 10mg | Drug | Oxycodone/ acetaminophen |
Primary outcome
Change in Pain Assessment
Time frame: 2 hours following treatment
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
4 secondary outcomes
Sustained Pain Relief
Time frame: Up to 48 hours following medication administration
Adequacy of Analgesia
Time frame: 2 hours following treatment
Satisfaction With Medication
Time frame: 2 hours following treatment
Medication-related Adverse Events
Time frame: 2 hours following treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Oxycodone in people with Musculoskeletal Pain, run by Montefiore Medical Center at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 28 Feb 2024). 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?
Change in Pain Assessment (time frame: 2 hours following treatment). 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 28 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.