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

NCT00580294 | Completed Results

• 1 other identifier: GCO 07-0464
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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; oxycodone

Outcome Measures

Primary Outcomes (2)

• Change in Patient Global Impression of Change

  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)

  baseline and 12 hours

• Brief Pain Inventory

  Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment

Study Arms (1)

oxymorphone

EXPERIMENTAL

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

Interventions

Oxymorphone DRUG

IV PO

Also known as: Oxymorphone PO, Oxymorphone IV

oxymorphone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Icahn School of Medcine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

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

  PMID: 21267044 RESULT

MeSH Terms

Conditions

Pain; Sciatica; Diabetic Neuropathies; Complex Regional Pain Syndromes; Low Back Pain; Neck Pain; Headache; Back Pain; Arthritis; Chronic Pain; Contracture; Diabetes Mellitus; Fibromyalgia; Fractures, Bone; Herpes Zoster; Migraine Disorders; Neuralgia; Osteoarthritis; Osteoporosis; Arthritis, Rheumatoid; Scoliosis

Interventions

Oxymorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Autonomic Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rheumatic Diseases; Wounds and Injuries; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Bone Diseases, Metabolic; Bone Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Curvatures; Spinal Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

This was a pilot open-label study in a small number of participants. A larger randomized study with long-term follow-up and comparison to traditional protocols is necessary to affirm safety. (12 pts had 6 different chronic non-cancer pain diagnoses.)

Results Point of Contact

• Title: Marco Pappagallo, MD
• Organization: Icahn School of Medicine at Mount Sinai

dionne.bobb@mountsinai.org

212-241-7749

Study Officials

• Marco Pappagallo, MD

  Icahn School of Medcine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 24, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2016-01

Locations

US (1)