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An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

Phase 3
18 Years
Not Enrolling
Chronic Pain, Neuropathic Pain, Cancer

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Trial Information

An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

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.

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,

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

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Throughout the study

Safety Issue:


Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Endo Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

August 2003

Completion Date:

May 2005

Related Keywords:

  • Chronic Pain
  • Neuropathic Pain
  • Cancer
  • Cancer Pain
  • Neuropathic Pain
  • Extended Release
  • Long-Acting Opioid
  • Oxymorphone
  • Neuralgia