Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Chronic PainNeuropathic PainCancer
Drug: Oxymorphone Extended Release
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
≥ 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)
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).
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