Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Pain, Neuropathic Pain, Cancer

Intervention / Treatment
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* Drug: Oxymorphone Extended Release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either: have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or have intolerable side effects to one or more components of their current opioid-containing analgesic regimen. Currently receive a stable (at least 2 weeks duration) analgesic regimen If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method). Understand written and spoken English Have been informed of the nature of the study and provided written informed consent Additional Inclusion Criteria for Cancer Patients Only: Have a life expectancy of at least 12 months Additional Inclusion Criteria for Neuropathic Patients Only: Have a diagnosis of: post-herpetic neuralgia (PHN) diabetic neuropathy (DN) complex regional pain syndrome (CRPS) HIV neuropathy idiopathic sensory neuropathy traumatic peripheral neuropathy central neuropathic pain condition (spinal cord injury, post-stroke pain), OR other peripheral neuropathy (upon mutual agreement of the sponsor and investigator). Exclusion Criteria: Have a positive pregnancy test (females only) Have a history of or active asthma or emphysema Have clinically significant hepatic impairment Have a history of alcohol or substance abuse within the last 3 years Have a history of opioid abuse within 6 months prior to study entry Have a known allergy or significant reaction to opioids, including codeine Have a known oxymorphone sensitivity or allergy Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: Oxymorphone Extended Release<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily pain intensity (Question 5 of BPI) |  | Week 1-4, Month 12 | 
| Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire |  | Week 1-4, Month 12 | 
| Average daily dose of oxymorphone ER |  | Daily | 
| Average daily dose of rescue medication |  | Daily | 
| Total daily dose of oxymorphone ER and rescue medication |  | Daily | 
| Time to stabilization |  | Month 12 | 
| Patient/investigator global assessment of pain relief |  | Month 12 | 
| Treatment Satisfaction |  | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Pain, Neuropathic Pain, Extended Release, Long-Acting Opioid, Oxymorphone