ArthritisPhase 4NCT01264965
Non-cancer Pain and Cognitive Impairment: A Disabling Relationship
A Phase 4 study testing long acting oxycodone and extra strength acetaminophen in people with Arthritis and Pain, run by University of Chicago at 1 site in United States.
Trial summary
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arthritis, Pain, Cognitive Impairment
- What is being tested?
- long acting oxycodone and extra strength acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2014
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age over 65
- Pain at least 3 months duration
- Pain greater in lower extremity than other anatomical site with ambulation
- Pain self-report of moderate intensity of higher on an average day
- Community-dwelling
- Ambulatory
Show all 9Show fewer
- Physician states participants have decision-making capacity to enroll into the trial
- Participants with cognitive impairment have a reliable caregiver
- Inadequate pain relief from NSAIDS and/or acetaminophen in the past
Who cannot join
- Current cancer requiring chemotherapy
- History of addiction to opioids or other controlled substance
- Consumes more than 2 alcoholic drinks a day
- Severe balance disturbance
- Intra-articular steroid injection in the past 6 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center Outpatient Senior Health Center South Shore
Chicago, Illinois, 60649
About this study
Official title: Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.
- Conditions
- Arthritis, Pain, Cognitive Impairment
- Being tested
- long acting oxycodone, extra strength acetaminophen
- Keywords
- Pain, Analgesia, Cognitive impairment, Randomized controlled trial, Physical function
- Medical subject headings
- Arthritis, Pain, Cognitive Dysfunction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long acting oxycodoneDrug
10mg twice daily
extra strength acetaminophenDrug
1,000 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | Not described Receives: Drug: extra strength acetaminophen |
| Long Acting Oxycodone | Active comparator | Not described Receives: Drug: long acting oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Self-report on the Brief Pain Inventory and WOMAC
Measured: 14 days
Secondary outcomes (1)
Discontinuation of Study Drug, Short Physical Performance Battery
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: recruitment problems
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 ArthritisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264965
- Sponsor's protocol ID
- 10-238-B
- Status last verified
- Nov 2020
- First submitted
- 20 Dec 2010
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain
- ClinicalTrials.gov ID
- NCT01264965
- Acronym / sponsor ID
- 10-238-B
- Conditions
- Arthritis, Pain, Cognitive Impairment
- Keywords
- Pain, Analgesia, Cognitive impairment, Randomized controlled trial, Physical function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problems
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: extra strength acetaminophen |
| Long Acting Oxycodone | Active comparator | Drug: long acting oxycodone |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- age over 65
- Pain at least 3 months duration
- Pain greater in lower extremity than other anatomical site with ambulation
- Pain self-report of moderate intensity of higher on an average day
- Community-dwelling
Key exclusion criteria (5 listed)
- Current cancer requiring chemotherapy
- History of addiction to opioids or other controlled substance
- Consumes more than 2 alcoholic drinks a day
- Severe balance disturbance
- Intra-articular steroid injection in the past 6 weeks
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 |
|---|---|---|
| long acting oxycodone10mg twice daily | Drug | Long Acting Oxycodone |
| extra strength acetaminophen1,000 mg twice daily | Drug | Acetaminophen |
Primary outcome
Pain Self-report on the Brief Pain Inventory and WOMAC
Time frame: 14 days
1 secondary outcome
Discontinuation of Study Drug, Short Physical Performance Battery
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 long acting oxycodone and extra strength acetaminophen in people with Arthritis and Pain, run by University of Chicago 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 9 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: stopped early, as of the sponsor's last update on 11 Dec 2020. 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 11 Dec 2020). 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 Self-report on the Brief Pain Inventory and WOMAC (time frame: 14 days). 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 11 Dec 2020.