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Completed

NCT Number: NCT00580294

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

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.

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Key information

Conditions

Pain Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autonomic Nervous System Diseases Back Pain Bone Diseases Bone Diseases, Metabolic Brain Diseases Central Nervous System Diseases Chronic Pain Complex Regional Pain Syndromes Connective Tissue Diseases Contracture DNA Virus Infections Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Fibromyalgia Fractures, Bone Glucose Metabolism Disorders Headache Headache Disorders Headache Disorders, Primary Herpes Zoster Herpesviridae Infections Immune System Diseases Infections Joint Diseases Low Back Pain Metabolic Diseases Migraine Disorders Mononeuropathies Muscular Diseases Musculoskeletal Diseases Neck Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Osteoarthritis Osteoporosis Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Sciatic Neuropathy Sciatica Scoliosis Signs and Symptoms Skin and Connective Tissue Diseases Spinal Curvatures Spinal Diseases Varicella Zoster Virus Infection Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medcine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxymorphone

Drug

IV PO

Other names: Oxymorphone PO, Oxymorphone IV

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 24, 2007
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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