Back to resultsOpen-Label Trial Comparing Oxycodone Medications (OUTCOMES)
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended Release Oxycodone
Immediate Release Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, This clinical trial will compare immediate-release (IR), oxycodone and extended-release (ER) oxycodone in the, management of chronic pain
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
ER Oxycodone vs IR Oxycodone
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Brief Pain Inventory
Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.
Hospital Anxiety and Depression Scale
The HADS will be administered to assess anxiety and depression.
Short Form Health Survey (SF-36)
It is a 36-item questionnaire designed to measure general health related quality of life.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01162304
Brief Title
Open-Label Trial Comparing Oxycodone Medications
Acronym
OUTCOMES
Official Title
Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
unable to enroll subjects meeting Eligibility criteria
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ER Oxycodone vs IR Oxycodone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Extended Release Oxycodone
Other Intervention Name(s)
Medication comparison
Intervention Description
40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
Intervention Type
Drug
Intervention Name(s)
Immediate Release Oxycodone
Other Intervention Name(s)
Medication comparison
Intervention Description
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
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NRS)
Description
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.
Time Frame
Daily
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Description
Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.
Time Frame
Visits 2-6
Title
Hospital Anxiety and Depression Scale
Description
The HADS will be administered to assess anxiety and depression.
Time Frame
Visits 2-6
Title
Short Form Health Survey (SF-36)
Description
It is a 36-item questionnaire designed to measure general health related quality of life.
Time Frame
Visits 2, 4 and 6
Title
Patient Global Impression of Change
Description
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.
Time Frame
Visits 4 and 6 the end of each of the two treatment periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel L Kent, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Open-Label Trial Comparing Oxycodone Medications
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