Open-Label Trial Comparing Oxycodone Medications (OUTCOMES)
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|ClinicalTrials.gov Identifier: NCT01162304|
Recruitment Status : Terminated (unable to enroll subjects meeting Eligibility criteria)
First Posted : July 14, 2010
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Extended Release Oxycodone Drug: Immediate Release Oxycodone||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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
Drug: Extended Release Oxycodone
40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
Other Name: Medication comparison
Drug: Immediate Release Oxycodone
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 Name: Medication comparison
- 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.
- 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.
- Hospital Anxiety and Depression Scale [ Time Frame: Visits 2-6 ]The HADS will be administered to assess anxiety and depression.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162304
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Joel L Kent, MD||University of Rochester|