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A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
This study has been completed.
Study NCT00580294   Information provided by Mount Sinai School of Medicine
First Received: December 19, 2007   Last Updated: August 19, 2008   History of Changes

December 19, 2007
August 19, 2008
November 2007
August 2008   (final data collection date for primary outcome measure)
  • Patient Global Impression of Change [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Brief Pain Inventory [ Time Frame: ssessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00580294 on ClinicalTrials.gov Archive Site
 
 
 
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

he 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 swithcing from one pain medication to another can be done over a 24 hour period. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain.

 
 
Interventional
Treatment, Open Label, Single Group Assignment
Pain
Drug: oxymorphone IV
Experimental: Drug
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
12
August 2008
August 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580294
Marco Pappagallo, Mount Sinai School of Medicine
GCO# 07-0464
Mount Sinai School of Medicine
Endo Pharmaceuticals
Principal Investigator: Marco Pappagallo, MD Mount Sinai School of Medcine
Mount Sinai School of Medicine
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP