Pain
Conditions
Keywords
Sciatica, Diabetic Neuropathies, Complex Regional Pain Syndromes, Low Back Pain, Neck Pain, Headache, Back Pain, Arthritis, Brachial Plexus Injury (stinger/burner), Chronic Pain, Contractures, Diabetes, Fibromyalgia, Foot Pain, Fracture, Hip, Herpes Zoster (shingles), Migraine, Neuropathic Pain, Osteoarthritis, Osteoporosis, Rheumatoid Arthritis, Scoliosis, Nerve pain, Opana, Opioid, Opioid Rotation, Oxymorphone, Morphine, neuropathic, oxycodone
Brief 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.
Interventions
DRUGOxymorphone
IV PO
Sponsors
Endo Pharmaceuticals
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Global Impression of Change | baseline and 12 hours | PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse) |
| Brief Pain Inventory | Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment | — |
Countries
United States
Participant flow
Recruitment details
study conducted at Mount Sinai School of Medicine, Department of Anesthesiology, Clinical Research Center (CRC), New York, NY, and enrolled patients from August 10, 2007 to August 9, 2008
Participants by arm
| Arm | Count |
|---|---|
| Oxymorphone oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Oxymorphone |
|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 12.4 |
| Average Pain Intensity | 7.34 units on a scale STANDARD_DEVIATION 1.18 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Brief Pain Inventory
Time frame: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment
Primary
Change in Patient Global Impression of Change
PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)
Time frame: baseline and 12 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oxymorphone | Change in Patient Global Impression of Change | 0.19 units on a scale |