Nervous System Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Neuralgia

Pain

Nociceptive Pain

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Oxycodone

Morphine

Analgesics, Opioid

Oxymorphone

Narcotics

Anesthetics

Oxymorphone ER

Marco Pappagallo

Marco Pappagallo, MD

This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.

This project will enroll 12 volunteers who suffer from chronic pain. Potential participants must be on one of the following therapies:

* Long acting morphine
* Oxycodone Participants will be asked to complete a pain diary for approximately 10 days and to stop taking their current pain medications the night before they are admitted o the GCRC. Once the patients present at the GCRC, they will be started on the IV PCA (Patient Controlled Analgesia) Oxymorphone to control their pain. Titration will take approximately a total of 8 hrs. At the end of the titration period, patients will be discharged home on OPANA ER. The oral dose will be calculated based on the IV PCA use. During the titration, patients' pain, vital and side effects will be assessed hourly until the 8th hour of the IV PCA titration.

Patients will be contacted daily by a member of the study team to assess pain and side effects. The OPANA ER dose will be adjusted as needed to adequately manage both.

If patients do not feel as though they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.

Patients will undergo an exit examination 2 weeks after they were admitted to the GCRC in order to assess pain relief. In addition, a final follow-up telephone interview will take place 6 weeks after the initial 1-day stay at the GCRC. Our research staff or physicians will ask about your pain treatment and ask which Opioid medication you are currently taking.

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

Endo Pharmaceuticals

Icahn School of Medicine at Mount Sinai

Marco Pappagallo, MD, Director of Pain Research and Development

Cancer Pain

Back Pain

Low Back Pain

Sr. Director

The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.

Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.

Sr. Director, Cliniacal R&D

Study Director

The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.

Open Label Assessment of Long-Term Safety and Utility

An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer

Sr. Director Clinical R&D

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	NCT00945919	Chronic Nocicep... Neuropathic Pai... Non-cancer Pain	Oxymorphone ER	18 Years -	Icahn School of Medicine at Mount Sinai
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy	NCT00904280	Cancers, Pain Lower Back Pain	Oxymorphone ER	18 Years - 75 Years	Endo Pharmaceuticals
Open Label Assessment of Long-Term Safety and Utility	NCT00904449	Pain	Oxymorphone ER	18 Years -	Endo Pharmaceuticals
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	NCT00945919	Chronic Nocicep... Neuropathic Pai... Non-cancer Pain	Oxymorphone ER	18 Years -	Icahn School of Medicine at Mount Sinai
Open Label Assessment of Long-Term Safety and Utility	NCT00904449	Pain	Oxymorphone ER	18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for oxymorphone er