- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162304
Open-Label Trial Comparing Oxycodone Medications (OUTCOMES)
Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ER Oxycodone vs IR Oxycodone
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 |
40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Daily
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory
Time Frame: Visits 2-6
|
Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.
|
Visits 2-6
|
Hospital Anxiety and Depression Scale
Time Frame: Visits 2-6
|
The HADS will be administered to assess anxiety and depression.
|
Visits 2-6
|
Short Form Health Survey (SF-36)
Time Frame: Visits 2, 4 and 6
|
It is a 36-item questionnaire designed to measure general health related quality of life.
|
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
|
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.
|
Visits 4 and 6 the end of each of the two treatment periods
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joel L Kent, MD, University of Rochester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29813
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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