Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

NCT00911261 | Completed Phase 3 DMC

• 1 other identifier: EN3202-029
• Study Type: interventional
• Target: 223
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Neuropathic Pain; Cancer

Keywords

Cancer Pain; Neuropathic Pain; Extended Release; Long-Acting Opioid; Oxymorphone

Outcome Measures

Primary Outcomes (1)

• Tolerability

  Throughout the study

Secondary Outcomes (8)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Oxymorphone Extended Release

Interventions

Oxymorphone Extended Release 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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Neoplasms; Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Study Director

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: June 1, 2009
• Study Start: August 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: May 1, 2005
• Last Updated: February 15, 2010

Record last verified: 2010-02