Clinical trial NCT00911261: Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
Official title: An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Neuropathic Pain
Cancer
Keywords: Cancer Pain
Neuropathic Pain
Extended Release
Long-Acting Opioid
Oxymorphone
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Tolerability
timeFrame: Throughout the study
Secondary outcomes:
measure: Average daily pain intensity (Question 5 of BPI)
timeFrame: Week 1-4, Month 12
measure: Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
timeFrame: Week 1-4, Month 12
measure: Average daily dose of oxymorphone ER
timeFrame: Daily
measure: Average daily dose of rescue medication
timeFrame: Daily
measure: Total daily dose of oxymorphone ER and rescue medication
timeFrame: Daily
measure: Time to stabilization
timeFrame: Month 12
measure: Patient/investigator global assessment of pain relief
timeFrame: Month 12
measure: Treatment Satisfaction
timeFrame: Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: