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A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00580294
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Endo Pharmaceuticals
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxymorphone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone
Study Start Date : November 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: oxymorphone
participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
Drug: Oxymorphone
Other Names:
  • Oxymorphone PO
  • Oxymorphone IV

Primary Outcome Measures :
  1. Change in Patient Global Impression of Change [ Time Frame: 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)

  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00580294

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United States, New York
Icahn School of Medcine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Endo Pharmaceuticals
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Principal Investigator: Marco Pappagallo, MD Icahn School of Medcine at Mount Sinai
Publications of Results:
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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00580294    
Other Study ID Numbers: GCO 07-0464
First Posted: December 24, 2007    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: January 2016
Keywords provided by Icahn School of Medicine at Mount Sinai:
Diabetic Neuropathies
Complex Regional Pain Syndromes
Low Back Pain
Neck Pain
Back Pain
Brachial Plexus Injury (stinger/burner)
Chronic Pain
Foot Pain
Herpes Zoster (shingles)
Neuropathic Pain
Rheumatoid Arthritis
Nerve pain
Opioid Rotation
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia