Clinical trial NCT00580294: A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
Official title: A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2007-12-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Patient Global Impression of Change
timeFrame: baseline and 12 hours
measure: Brief Pain Inventory
timeFrame: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medcine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medcine at Mount Sinai
name: Marco Pappagallo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korkmazsky M, Ghandehari J, Sanchez A, Lin HM, Pappagallo M. Feasibility study of rapid opioid rotation and titration. Pain Physician. 2011 Jan-Feb;14(1):71-82.