PainPhase 4NCT02703610
Randomized Trial of Two Analgesics in Elderly ED Patients
A Phase 4 study testing Oxycodone/acetaminophen and Ibuprofen/acetaminophen in people with Pain, run by Albany Medical College at 1 site in United States.
Trial summary
The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Oxycodone/acetaminophen and Ibuprofen/acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Complaint of acute pain of < 7 days duration
- ED attending plans to discharge patient home with an oral analgesic
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
- Ibuprofen or acetaminophen or opioids taken in past 4 hours
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.
Read the detailed description
To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows:
- Oxycodone/acetaminophen (5/325)
- Ibuprofen/acetaminophen (400/500)
- Conditions
- Pain
- Being tested
- Oxycodone/acetaminophen, Ibuprofen/acetaminophen
- Keywords
- Pain, Elderly
- 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
Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen
Ibuprofen/acetaminophenDrug
Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone/acetaminophen | Active comparator | Oxycodone/acetaminophen (5 mg/325 mg) Receives: Drug: Oxycodone/acetaminophen |
| Ibuprofen/acetaminophen | Active comparator | Ibuprofen/acetaminophen (400 mg/500 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 NRS pain scores
Between group difference in change in NRS pain scores at 24 hours
Measured: 24 hours
Secondary outcomes (9)
Between group difference in change in NRS pain scores at first followup contact
Between group difference in change in NRS pain scores at first followup contact
Measured: 24-72 hours
Between group difference in change in NRS pain scores
Between group difference in change in NRS pain scores at 48 hours and 72 hours
Measured: 48 hours and 72 hours
Between group difference in side effects
Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)
Measured: 24 hours, 48 hours and 72 hours
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Measured: 24 hours
Between group difference in Likert pain scores
Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)
Measured: 24, 48, and 72 hours
Satisfaction
Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Measured: 24, 48, and 72 hours
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Measured: 24-72 hours
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Measured: 24-72 hours
Want same medication again
Between group difference in proportion of patients who would want the same medication again
Measured: 24-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Why it stopped: No participants were enrolled and the study will not be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Chang, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703610
- Sponsor's protocol ID
- 4733
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Two Analgesics in Elderly ED Patients
- ClinicalTrials.gov ID
- NCT02703610
- Acronym / sponsor ID
- 4733
- Conditions
- Pain
- Keywords
- Pain, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled and the study will not be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
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 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.
Detailed description
To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows:
- Oxycodone/acetaminophen (5/325)
- Ibuprofen/acetaminophen (400/500)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone/acetaminophen | Active comparator | Drug: Oxycodone/acetaminophenOxycodone/acetaminophen (5 mg/325 mg) |
| Ibuprofen/acetaminophen | Active comparator | Drug: Ibuprofen/acetaminophenIbuprofen/acetaminophen (400 mg/500 mg) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Complaint of acute pain of < 7 days duration
- ED attending plans to discharge patient home with an oral analgesic
Key exclusion criteria (8 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
- Ibuprofen or acetaminophen or opioids taken in past 4 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: PercocetPatients will be discharged home with a 3 day supply of oxycodone/acetaminophen | Drug | Oxycodone/acetaminophen |
| Ibuprofen/acetaminophenPatients will be discharged home with a 3 day supply of ibuprofen/acetaminophen | Drug | Ibuprofen/acetaminophen |
Primary outcome
Between group difference in change in NRS pain scores
Time frame: 24 hours
Between group difference in change in NRS pain scores at 24 hours
9 secondary outcomes
Between group difference in change in NRS pain scores at first followup contact
Time frame: 24-72 hours
Between group difference in change in NRS pain scores
Time frame: 48 hours and 72 hours
Between group difference in side effects
Time frame: 24 hours, 48 hours and 72 hours
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Time frame: 24 hours
Between group difference in Likert pain scores
Time frame: 24, 48, and 72 hours
Satisfaction
Time frame: 24, 48, and 72 hours
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Time frame: 24-72 hours
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Time frame: 24-72 hours
Want same medication again
Time frame: 24-72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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 Oxycodone/acetaminophen and Ibuprofen/acetaminophen in people with Pain, run by Albany Medical College 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 8 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: withdrawn, as of the sponsor's last update on 21 Sep 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 NRS pain scores (time frame: 24 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 21 Sep 2023.