Chronic Disease, Pain
Conditions
Keywords
Chronic pain, Extended Release, Long-Acting Opioid, Opioid, Opioid-Naive, Oxymorphone
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.
Interventions
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.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability. | Entire study duration, including follow-up period. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period | Week 1-4, Month 1-6 |
| Time to stabilization. Patient/investigator global assessments | Month 6 |
| Treatment satisfaction | Month 6 |
| Total daily dose of oxymorphone ER and rescue medication | Entire study duration |
Outcome results
None listed