N/A
Completed N=12
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
Source: ClinicalTrials.gov NCT00580294 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Change in Patient Global Impression of Change — 0.19 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Global Impression of Change |
0.19 | — |
| PRIMARY Brief Pain Inventory |
— | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00580294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.