A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) - Full Text View

Purpose

he 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 swithcing 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

Drug Information available for:

Oxycodone Oxycodone hydrochloride Oxymorphone Oxymorphone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment

Official Title:	A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

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: ssessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment ] [ Designated as safety issue: No ]

Estimated 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
1: Experimental Drug	Drug: oxymorphone IV IV 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

Responsible Party:	Mount Sinai School of Medicine ( Marco Pappagallo )
Study ID Numbers:	GCO# 07-0464
First Received:	December 19, 2007
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00580294
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

Fibromyaglia

Foot Pain

Fracture

Hip

Herpes Zoster (shingles)

Migraine

Neuropathic Pain

Osteoarthritis

Osteoporosis

Rheumatoid Arthritis

Scoliosis

Chronic Pain

Nerve pain

Opana

Opioid

Opioid Rotation

Oxymorphone

Morphine

Study placed in the following topic categories:

Herpes Zoster

Morphine

Scoliosis

Diabetic Neuropathies

Osteoarthritis

Oxycodone

Fractures, Bone

Neck Pain

Diabetes Mellitus

Arthritis, Rheumatoid

Osteoporosis

Low Back Pain

Pain

Back Pain

Oxymorphone

Sciatica

Complex Regional Pain Syndromes

Contracture

Migraine Disorders

Arthritis

Headache

Additional relevant MeSH terms:

Adjuvants, Anesthesia

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Mount Sinai School of Medicine Endo Pharmaceuticals
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00580294