A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) (NCT00580294) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
United States12 participantsStarted 2007-11
Plain-language summary
The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of 18 to no upper limit
* Chronic pain of nociceptive, neuropathic, or mixed origin
* Patients with chronic non cancer pain
* Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
* Pain of moderate intensity (\>4, on the numerical scale 0-10) despite ongoing opioid therapy\>
* Non-pregnant, non-lactating women
* Sufficient language skills to communicate with research staff
Exclusion Criteria:Non-ambulatory patients
* Clinically significant respiratory, renal, hepatic, or cardiac disease.
* Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
* History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
* Severe depression (\> 26 on the BDI)
* Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).
* Workman compensation, current or pending medical-legal litigation
* Hypersensitivity to study medication (oxymorphone)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient Global Impression of Change
Timeframe: baseline and 12 hours
2
Brief Pain Inventory
Timeframe: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment