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):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00580294
First received: December 19, 2007
Last updated: January 4, 2016
Last verified: January 2016
  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. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Condition Intervention
Pain
Drug: Oxymorphone

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 Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Change in Patient Global Impression of Change [ Time Frame: baseline and 12 hours ] [ Designated as safety issue: No ]
    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)

  • 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: 12
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: 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
IV PO
Other Names:
  • Oxymorphone PO
  • Oxymorphone IV

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580294

Locations
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
Investigators
Principal Investigator: Marco Pappagallo, MD Icahn School of Medcine at Mount Sinai
  More Information

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00580294     History of Changes
Other Study ID Numbers: GCO 07-0464 
Study First Received: December 19, 2007
Results First Received: November 25, 2015
Last Updated: January 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Icahn School of Medicine at Mount Sinai:
Brachial Plexus Injury (stinger/burner)
Sciatica
Diabetic Neuropathies
Complex Regional Pain Syndromes
Low Back Pain
Neck Pain
Headache
Back Pain
Arthritis
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
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 25, 2016