Chronic PainPhase 4OUTCOMESNCT01162304
Open-Label Trial Comparing Oxycodone Medications
A Phase 4 study testing Extended Release Oxycodone and Immediate Release Oxycodone in people with Chronic Pain, run by University of Rochester at 1 site in United States.
Trial summary
The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) medication as they… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Extended Release Oxycodone and Immediate Release Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old.
- Be able to read and understand English.
- Have a diagnosed chronic pain condition with pain every day or most days for the previous 6 months.
- Be receiving the equivalent of no more than 40-120 mg daily of an opioid analgesic that can be safely converted to oxycodone; this dosage includes all use of opioid analgesics, including for "rescue" and for "breakthrough" pain.
- Have an average daily pain rating for the baseline week of pain ratings equal to 4.0 or greater on a 0-10 numerical pain rating scale (NRS) of average pain intensity in the past 24 hours.
- Have completed at least 6 of the 7 daily diaries during the baseline week.
Show all 9Show fewer
- Have at least 5 baseline week pain diary ratings equal to 3 or greater on the 0-10 NRS, with no more than one rating of 9 and no ratings of 10.
- Have stable concomitant use of all pain-related medications for 8 weeks prior to screening and being willing to continue stable use of these medications for the duration of the trial.
- Have the ability to either independently or with an accompanying person come to the research center for study visits.
Who cannot join
- Treatment of their chronic pain with nerve blocks or any other interventional procedure within the past 8 weeks.
- A Beck Depression Inventory score < 27 at baseline or clinically significant depression or dementia that, in the opinion of the investigator, may interfere with a subjects' adherence to the study protocol and/or the accurate and consistent reporting of pain.
- History of suicide attempt within the past 2 years or current suicide plan or intent.
- History of excessive alcohol use or any illicit drug use within the past 2 years.
- Lack of adequate birth control in pre-menopausal women of child-bearing age and/or a positive urine pregnancy test, which will be performed on all women except those > 2 years post-menopausal or who have had a hysterectomy).
- History of malignancy within the past five years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)
The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) medication as they need to control their pain. In addition, the ability to vary the medication doses in this way will give them a greater sense of control, which will also contribute to greater pain relief. Similarly, the investigators predict that patients will show greater benefits with IR-oxycodone on the measures of physical and emotional functioning. Because there is relatively little data on sleep apnea in chronic pain patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based. Finally, although it is typically thought that the abuse liability of IR-opioid medications is greater than for ER-medications, the data on which this belief are based have not involved systematic studies of patients with chronic pain; the assessments of abuse liability will therefore also be exploratory.
Read the detailed description
This study is a single-center, randomized, open-label, 13-week, 2-period crossover clinical trial. Subjects will complete each of the following (unless they withdraw from the trial): (1) a one-week baseline period during which the subject completes pain diaries and remains on stable dosages of their existing pain medications; (2) immediate-release (IR) oxycodone 5 mg 3-4 pills every four hours; (3) extended-release (ER) oxycodone 40 mg 1 pill every 12 hours and IR-oxycodone 5 mg 1-2 pills every six hours. Subjects will be randomized to one of two treatment sequences (ER-oxycodone first then IR-oxycodone or vice verse). It is expected that this trial will take approximately 2 years to complete.
Crossover periods. Each of the two treatment periods will be 6 weeks in duration, which will allow ample time to assess pain relief, adverse effects, treatment satisfaction, and impact of treatment on health-related quality of life. There will be no need for a titration period at the beginning of either period or for a washout period before the second period because oxycodone at the same dosages will be administered in both periods. At each visit, subjects will be given sufficient medication to sustain them until at least the following visit.
- Conditions
- Chronic Pain
- Being tested
- Extended Release Oxycodone, Immediate Release Oxycodone
- Keywords
- Chronic Pain, This clinical trial will compare immediate-release (IR), oxycodone and extended-release (ER) oxycodone in the, management of chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release OxycodoneDrug
Also called Medication comparison
40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
Immediate Release OxycodoneDrug
Also called Medication comparison
IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
| Study group | Role | What they receive |
|---|---|---|
| ER Oxycodone vs IR Oxycodone | Active comparator | Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Receives: Drug: Extended Release Oxycodone; Drug: Immediate Release Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NRS)
The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.
Measured: Daily
Secondary outcomes (4)
Brief Pain Inventory
Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.
Measured: Visits 2-6
Hospital Anxiety and Depression Scale
The HADS will be administered to assess anxiety and depression.
Measured: Visits 2-6
Short Form Health Survey (SF-36)
It is a 36-item questionnaire designed to measure general health related quality of life.
Measured: Visits 2, 4 and 6
Patient Global Impression of Change
This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.
Measured: Visits 4 and 6 the end of each of the two treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: unable to enroll subjects meeting Eligibility criteria
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 Chronic 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Kent, University of Rochester
- Investigators
- Joel L Kent, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162304
- Sponsor's protocol ID
- 29813
- Acronym
- OUTCOMES
- Status last verified
- Jan 2014
- First submitted
- 27 Apr 2010
- Last updated
- 17 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)
- ClinicalTrials.gov ID
- NCT01162304
- Acronym / sponsor ID
- OUTCOMES / 29813
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, This clinical trial will compare immediate-release (IR), oxycodone and extended-release (ER) oxycodone in the, management of chronic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll subjects meeting Eligibility criteria
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Posted 17 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) medication as they need to control their pain. In addition, the ability to vary the medication doses in this way will give them a greater sense of control, which will also contribute to greater pain relief. Similarly, the investigators predict that patients will show greater benefits with IR-oxycodone on the measures of physical and emotional functioning. Because there is relatively little data on sleep apnea in chronic pain patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based. Finally, although it is typically thought that the abuse liability of IR-opioid medications is greater than for ER-medications, the data on which this belief are based have not involved systematic studies of patients with chronic pain; the assessments of abuse liability will therefore also be exploratory.
Detailed description
This study is a single-center, randomized, open-label, 13-week, 2-period crossover clinical trial. Subjects will complete each of the following (unless they withdraw from the trial): (1) a one-week baseline period during which the subject completes pain diaries and remains on stable dosages of their existing pain medications; (2) immediate-release (IR) oxycodone 5 mg 3-4 pills every four hours; (3) extended-release (ER) oxycodone 40 mg 1 pill every 12 hours and IR-oxycodone 5 mg 1-2 pills every six hours. Subjects will be randomized to one of two treatment sequences (ER-oxycodone first then IR-oxycodone or vice verse). It is expected that this trial will take approximately 2 years to complete.
Crossover periods. Each of the two treatment periods will be 6 weeks in duration, which will allow ample time to assess pain relief, adverse effects, treatment satisfaction, and impact of treatment on health-related quality of life. There will be no need for a titration period at the beginning of either period or for a washout period before the second period because oxycodone at the same dosages will be administered in both periods. At each visit, subjects will be given sufficient medication to sustain them until at least the following visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ER Oxycodone vs IR Oxycodone | Active comparator | Drug: Extended Release Oxycodone, Drug: Immediate Release OxycodoneExtended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life. IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be at least 18 years old.
- Be able to read and understand English.
- Have a diagnosed chronic pain condition with pain every day or most days for the previous 6 months.
- Be receiving the equivalent of no more than 40-120 mg daily of an opioid analgesic that can be safely converted to oxycodone; this dosage includes all use of opioid analgesics, including for "rescue" and for "breakthrough" pain.
- Have an average daily pain rating for the baseline week of pain ratings equal to 4.0 or greater on a 0-10 numerical pain rating scale (NRS) of average pain intensity in the past 24 hours.
Key exclusion criteria (6 listed)
- Treatment of their chronic pain with nerve blocks or any other interventional procedure within the past 8 weeks.
- A Beck Depression Inventory score < 27 at baseline or clinically significant depression or dementia that, in the opinion of the investigator, may interfere with a subjects' adherence to the study protocol and/or the accurate and consistent reporting of pain.
- History of suicide attempt within the past 2 years or current suicide plan or intent.
- History of excessive alcohol use or any illicit drug use within the past 2 years.
- Lack of adequate birth control in pre-menopausal women of child-bearing age and/or a positive urine pregnancy test, which will be performed on all women except those > 2 years post-menopausal or who have had a hysterectomy).
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 |
|---|---|---|
| Extended Release OxycodoneAlso: Medication comparison40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours | Drug | ER Oxycodone vs IR Oxycodone |
| Immediate Release OxycodoneAlso: Medication comparisonIR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours | Drug | ER Oxycodone vs IR Oxycodone |
Primary outcome
Numerical Pain Rating Scale (NRS)
Time frame: Daily
The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.
4 secondary outcomes
Brief Pain Inventory
Time frame: Visits 2-6
Hospital Anxiety and Depression Scale
Time frame: Visits 2-6
Short Form Health Survey (SF-36)
Time frame: Visits 2, 4 and 6
Patient Global Impression of Change
Time frame: Visits 4 and 6 the end of each of the two treatment periods
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- 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.
Joel L Kent, MD principal investigator
University of Rochester
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 Extended Release Oxycodone and Immediate Release Oxycodone in people with Chronic Pain, run by University of Rochester 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 6 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 17 Jul 2015. 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 17 Jul 2015). 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?
Numerical Pain Rating Scale (NRS) (time frame: Daily). 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 17 Jul 2015.