PainPhase 4NCT02455518
Comparative Efficacy of 4 Oral Analgesics
A Phase 4 study testing Oxycodone/acetaminophen, Hydrocodone/acetaminophen and Codeine/acetaminophen in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Oxycodone/acetaminophen, Hydrocodone/acetaminophen and Codeine/acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 4 Oct 2017
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaint of acute pain of < 7 days duration
- Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
- Radiologic evaluation is planned
Who cannot join
- Inability to confirm reliable means of phone followup.
- Past use of methadone
- Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
- History of an adverse reaction to any of the study medications
- Opioids taken in the past 24 hours
- Ibuprofen or acetaminophen taken in past 8 hours
Show all 12Show fewer
- Pregnancy by either urine or serum HCG testing
- Breastfeeding per patient report
- History of peptic ulcer disease
- Report of any prior use of recreational narcotics
- Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
- Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
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: Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain
The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.
Read the detailed description
To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:
- Oxycodone/acetaminophen (5/325)
- Hydrocodone/acetaminophen (5/325)
- Codeine/acetaminophen (30/300)
- Ibuprofen/acetaminophen (400/1000)
- Conditions
- Pain
- Being tested
- Oxycodone/acetaminophen, Hydrocodone/acetaminophen, Codeine/acetaminophen, Ibuprofen/acetaminophen
- Keywords
- pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone/acetaminophenDrug
Also called Percocet
Hydrocodone/acetaminophenDrug
Also called Norco
Codeine/acetaminophenDrug
Also called Tylenol with codeine
Ibuprofen/acetaminophenDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone/acetaminophen | Active comparator | Oxycodone/acetaminophen (5 mg/325 mg) Receives: Drug: Oxycodone/acetaminophen |
| Hydrocodone/acetaminophen | Active comparator | Hydrocodone/acetaminophen (5 mg/300 mg) Receives: Drug: Hydrocodone/acetaminophen |
| Codeine/acetaminophen | Active comparator | Codeine/acetaminophen (30 mg/300 mg) Receives: Drug: Codeine/acetaminophen |
| Ibuprofen/acetaminophen | Active comparator | Ibuprofen/acetaminophen (400 mg/1000 mg) Receives: Drug: Ibuprofen/acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Measured: 2 hours
Secondary outcomes (1)
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completion4 Oct 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Chang, MD, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455518
- Sponsor's protocol ID
- 2014-4156
- Status last verified
- Feb 2018
- First submitted
- 22 May 2015
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
PubMed 29114833
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain
- ClinicalTrials.gov ID
- NCT02455518
- Acronym / sponsor ID
- 2014-4156
- Conditions
- Pain
- Keywords
- pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Posted 13 Feb 2018
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 perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.
Detailed description
To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:
- Oxycodone/acetaminophen (5/325)
- Hydrocodone/acetaminophen (5/325)
- Codeine/acetaminophen (30/300)
- Ibuprofen/acetaminophen (400/1000)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxycodone/acetaminophen | Active comparator | Drug: Oxycodone/acetaminophenOxycodone/acetaminophen (5 mg/325 mg) |
| Hydrocodone/acetaminophen | Active comparator | Drug: Hydrocodone/acetaminophenHydrocodone/acetaminophen (5 mg/300 mg) |
| Codeine/acetaminophen | Active comparator | Drug: Codeine/acetaminophenCodeine/acetaminophen (30 mg/300 mg) |
| Ibuprofen/acetaminophen | Active comparator | Drug: Ibuprofen/acetaminophenIbuprofen/acetaminophen (400 mg/1000 mg) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complaint of acute pain of < 7 days duration
- Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
- Radiologic evaluation is planned
Key exclusion criteria (12 listed)
- Inability to confirm reliable means of phone followup.
- Past use of methadone
- Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
- History of an adverse reaction to any of the study medications
- Opioids taken in the past 24 hours
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 |
|---|---|---|
| Oxycodone/acetaminophenAlso: Percocet | Drug | Oxycodone/acetaminophen |
| Hydrocodone/acetaminophenAlso: Norco | Drug | Hydrocodone/acetaminophen |
| Codeine/acetaminophenAlso: Tylenol with codeine | Drug | Codeine/acetaminophen |
| Ibuprofen/acetaminophen | Drug | Ibuprofen/acetaminophen |
Primary outcome
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Time frame: 2 hours
Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
1 secondary outcome
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29114833Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 Oxycodone/acetaminophen, Hydrocodone/acetaminophen and Codeine/acetaminophen in people with 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 3 inclusion and 12 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 13 Feb 2018. 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 13 Feb 2018). 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?
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455518, which also lists 1 linked publication.
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 13 Feb 2018.