Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.

Detailed Description
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The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.

Official Title
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An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.

Conditions
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Pain, Chronic Disease

Intervention / Treatment
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* Drug: Oxymorphone extended release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently receive a stable non-opioid analgesic regimen Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe If female, must be practicing abstinence or using a medically acceptable form of contraception Understand written and spoken English Have been informed of the nature of the study and provided written informed consent. Exclusion Criteria: Positive pregnancy test (females only) History of or active asthma or emphysema Clinically significant hepatic impairment Received any of the following medications within 48 hours prior to dosing: Dextromethorphan-containing medications (over-the-counter [OTC] cough and cold preparations, such as Vicks Formula 44) St. John's Wort >1000 mg/day Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing Are not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs Serotonin reuptake inhibitors Amphetamines used for attention-deficit/hyperactivity disorder (ADHD) History of alcohol or substance abuse within the last 3 years History of opioid abuse within 6 months prior to study entry Have a known oxymorphone sensitivity or allergy Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient 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 Have a known allergy or significant reaction to opioids Have been a participant in a previous oxymorphone clinical trial Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).

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, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 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. |  | Entire study duration, including follow-up period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period |  | Week 1-4, Month 1-6 | 
| Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire |  | Week 1-4, Month 1-6 | 
| Average daily dose of oxymorphone ER |  | Entire study duration | 
| Rescue medication. |  | Entire study duration | 
| Total daily dose of oxymorphone ER and rescue medication |  | Entire study duration | 
| Time to stabilization. Patient/investigator global assessments |  | Month 6 | 
| Treatment satisfaction |  | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Extended Release, Long-Acting Opioid, Opioid, Opioid-Naive, Oxymorphone