Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

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 determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.

Study Overview

• Status: Completed
• Conditions: Cancer; Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Drug: Oxymorphone Extended Release

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.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single Arm	Drug: Oxymorphone Extended Release; Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets; Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets; Treatment will consist of up to 12 months of dosing with Oxymorphone ER.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerability	Throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Average daily pain intensity (Question 5 of BPI)	Week 1-4, Month 12
Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire	Week 1-4, Month 12
Average daily dose of oxymorphone ER	Daily
Average daily dose of rescue medication	Daily
Total daily dose of oxymorphone ER and rescue medication	Daily
Time to stabilization	Month 12
Patient/investigator global assessment of pain relief	Month 12
Treatment Satisfaction	Month 12

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (ACTUAL): March 1, 2005
• Study Completion (ACTUAL): May 1, 2005

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (ESTIMATE): June 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2010
• Last Update Submitted That Met QC Criteria: February 12, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Cancer Pain; Neuropathic Pain; Extended Release; Oxymorphone; Long-Acting Opioid
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxymorphone
• Other Study ID Numbers: EN3202-029