Status:
TERMINATED
Open-Label Trial Comparing Oxycodone Medications
Lead Sponsor:
University of Rochester
Conditions:
Chronic Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
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 ba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01162304
Start Date
March 1 2010
End Date
December 1 2013
Last Update
July 17 2015
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642