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

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00580294
First received: December 19, 2007
Last updated: March 7, 2012
Last verified: July 2011
  Purpose

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. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain.


Condition Intervention
Pain
Drug: oxymorphone IV

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Patient Global Impression of Change [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug
Drug: oxymorphone IV
IV PO
Other Name: Oxymorphone PO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580294

Locations
United States, New York
Mount Sinai School of Medcine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Endo Pharmaceuticals
Investigators
Principal Investigator: Marco Pappagallo, MD Mount Sinai School of Medcine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00580294     History of Changes
Other Study ID Numbers: GCO# 07-0464
Study First Received: December 19, 2007
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
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

Additional relevant MeSH terms:
Oxymorphone
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014