Status:
UNKNOWN
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Chronic Nociceptive Pain
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended ...
Detailed Description
This project will enroll 12 volunteers who suffer from chronic pain. Potential participants must be on one of the following therapies: * Long acting morphine * Oxycodone Participants will be asked to...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- 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 three months and at least a total daily Opioid dose of 60mg 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
- 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 probably sleep apnea).
- History of illicit drug or alcohol dependence or abuse, abnormal drug taking/seeking behaviors.
- Sever depression (\> 26 on the BDI) or severe anxiety or insomnia requiring chronic daily use of benzodiazepines or hypnotic drugs.
- 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).
- Hypersensitivity to study medication (Oxymorphone).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00945919
Start Date
July 1 2009
End Date
May 1 2011
Last Update
July 24 2009
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029