Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Oxymorphone

Criteria

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:

1. 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

2. 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