Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00580294
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
IV PO
Other Names:
  • Oxymorphone PO
  • Oxymorphone IV


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00580294


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Marco Pappagallo, MD Icahn School of Medcine at Mount Sinai
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov 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:
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:
Layout table for MeSH terms
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia