Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
- Registration Number
- NCT00911287
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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.
-
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)
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History of alcohol or substance abuse within the last 3 years
-
History of opioid abuse within 6 months prior to study entry
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Have a known oxymorphone sensitivity or allergy
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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
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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
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Have a known allergy or significant reaction to opioids
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Have been a participant in a previous oxymorphone clinical trial
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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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Oxymorphone extended release -
- Primary Outcome Measures
Name Time Method Tolerability. Entire study duration, including follow-up period.
- Secondary Outcome Measures
Name Time Method 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