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they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.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

Chronic Pain

Cancer Pain

* Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets
* Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets
* Treatment will consist of up to 12 months of dosing with Oxymorphone ER.

Oxymorphone Extended Release

Study Director

The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.

The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.

Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

Sr. Director, CR&D

Antitussive Agents

Respiratory System Agents

Anti-Obesity Agents

Vasoconstrictor Agents

Hydromorphone

Hydrocodone

Levorphanol

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.

Questionnaire Administration

Akhila S Reddy

This early phase I trial studies how well levorphanol works as a second line opioid in reducing pain in patients with cancer that may have spread to other places in the body. Levorphanol may work better in controlling cancer pain.

PRIMARY OBJECTIVE:

I. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol at the primary end point.

SECONDARY OBJECTIVES:

I. To determine the median opioid rotation ratio (ORR) in patients undergoing successful opioid rotations from morphine equivalent daily dose (MEDD) to levorphanol in the Supportive Care Center (SCC) or Pain Clinic.

II. To determine the effect of levorphanol on cancer pain (as measured by change in Edmonton Symptom Assessment System's \[ESAS\] pain item from baseline) in cancer outpatients undergoing opioid rotation to levorphanol at the primary end point of treatment.

III. To determine the association between the opioid rotation ratio from MEDD to levorphanol and baseline MEDD prior to opioid rotation.

IV. Measure levorphanol related side effects using the opioid side effect scale at day 10 +/- 1 of starting levorphanol.

V. Determine what percentage of patients rotated to levorphanol achieve their personalized pain goal.

VI. Determine the predictors of successful opioid rotation from other opioids to levorphanol.

OUTLINE:

Patients receive levorphanol orally (PO) every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.

Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer

Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study

Bayesian methodology developed by Peter Thall will be used to monitor the study. This method decides whether levorphanol is promising relative to the standard medicine. Will estimate the proportion of successful opioid rotation along with a 95% confidence interval. Association between successful opioid rotation and demographic/clinical characteristics will be examined by Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will be employed to assess the effect of demographic/clinical characteristics on the presence of successful opioid rotation.

Will be calculated by levorphanol mg (day 10 +/- 1) over MEDD (day 0). ORR will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on ORR between/among patients' characteristics groups.

Pain score change will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on pain score change between/among patients' characteristics groups. Since ESAS pain score will be measured daily from day 0 to day 10 +/- 1 and on day 30 +/- 3, mixed model will be applied to examine the differential changes over time for ESAS pain score, adjusting for other covariates of interest. ORR and baseline MEDD will be presented by scatter plots. Correlation will be assessed between levorphanol dose on day 10 +/- 1, ORR and baseline MEDD suing Pearson or Spearman correlation coefficient when appropriate. Linear regression models will be applied to estimate the linear association between levorphanoal dose on day 10 +/- 1, ORR and baseline MEDD.

Will be rated using the Opioid Side Effect Scale on xerostmia, nauseas, constipation, drowsiness and confusion daily from day 0 to day 10 +/-1 and on day 30 +/- 3.

PPG will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Mixed model will be applied to examine the differential changes over time for opioid side effect scale, adjusting for other covariates of interest. The goal is not achieved if the PPG is lower than the ESAS pain score. Frequency and proportion of achieved goal will be summarized.

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
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain	NCT00911261	Chronic Pain Neuropathic Pai... Cancer	Oxymorphone Ext...	18 Years -	Endo Pharmaceuticals
Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer	NCT03579446	Hematopoietic a... Malignant Solid... Metastatic Mali...	Hydrocodone Hydromorphone Levorphanol Morphine Oxycodone Oxymorphone Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer	NCT03579446	Hematopoietic a... Malignant Solid... Metastatic Mali...	Hydrocodone Hydromorphone Levorphanol Morphine Oxycodone Oxymorphone Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
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
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain	NCT00911261	Chronic Pain Neuropathic Pai... Cancer	Oxymorphone Ext...	18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for oxymorphone

Every month we try and update this database with for oxymorphone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oxymorphone

Every month we try and update this database with for oxymorphone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oxymorphone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.