Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

NCT ID: NCT00911261

Last Updated: 2010-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2005-05-31

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.

Conditions

Chronic Pain; Neuropathic Pain; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

Oxymorphone Extended Release

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: DRUG

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

• Have a life expectancy of at least 12 months

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals Inc.

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Other Identifiers

EN3202-029

Identifier Type: -

Identifier Source: org_study_id