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| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymorphone | Drug | IV PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:Non-ambulatory patients
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| Name | Affiliation | Role |
|---|---|---|
| Marco Pappagallo, MD | Icahn School of Medcine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medcine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21267044 | Result | 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. |
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study conducted at Mount Sinai School of Medicine, Department of Anesthesiology, Clinical Research Center (CRC), New York, NY, and enrolled patients from August 10, 2007 to August 9, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxymorphone | oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 12 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxymorphone | oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control. |
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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.)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Pappagallo, MD | Icahn School of Medicine at Mount Sinai | 212-241-7749 | dionne.bobb@mountsinai.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D012585 | Sciatica |
| D003929 | Diabetic Neuropathies |
| D020918 | Complex Regional Pain Syndromes |
| D017116 | Low Back Pain |
| D019547 | Neck Pain |
| D006261 | Headache |
| D001416 | Back Pain |
| D001168 | Arthritis |
| D059350 | Chronic Pain |
| D003286 | Contracture |
| D003920 | Diabetes Mellitus |
| D005356 | Fibromyalgia |
| D050723 | Fractures, Bone |
| D006562 | Herpes Zoster |
| D008881 | Migraine Disorders |
| D009437 | Neuralgia |
| D010003 | Osteoarthritis |
| D010024 |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020426 | Sciatic Neuropathy |
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| ID | Term |
|---|---|
| D010111 | Oxymorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Average Pain Intensity | Brief Pain Inventory average daily pain (0= no pain, 10=worst imaginable pain) | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Brief Pain Inventory | Not Posted | Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment |
| 0 |
| 12 |
| 0 |
| 12 |
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| Osteoporosis |
| D001172 | Arthritis, Rheumatoid |
| D012600 | Scoliosis |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012216 | Rheumatic Diseases |
| D014947 | Wounds and Injuries |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |