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

This study has been completed.

First Received on December 19, 2007. Last Updated on July 8, 2011 History of Changes

Sponsor:	Mount Sinai School of Medicine
Collaborator:	Endo Pharmaceuticals
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00580294

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:

MedlinePlus related topics: Back Pain

Drug Information available for: Oxymorphone Oxymorphone hydrochloride

U.S. FDA Resources

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):

Korkmazsky M, Ghandehari J, Sanchez A, Lin HM, Pappagallo M. Feasibility study of rapid opioid rotation and titration. Pain Physician. 2011 Jan;14(1):71-82.

Responsible Party:	Marco Pappagallo, 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:	July 8, 2011
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 February 12, 2012