Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911261
• Other study ID #: EN3202-029
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2009
• Last updated: February 12, 2010
• Start date: August 2003
• Est. completion date: May 2005

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: May 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer
• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability		Throughout the study	Yes
Secondary	Average daily pain intensity (Question 5 of BPI)		Week 1-4, Month 12	No
Secondary	Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire		Week 1-4, Month 12	No
Secondary	Average daily dose of oxymorphone ER		Daily	No
Secondary	Average daily dose of rescue medication		Daily	No
Secondary	Total daily dose of oxymorphone ER and rescue medication		Daily	No
Secondary	Time to stabilization		Month 12	No
Secondary	Patient/investigator global assessment of pain relief		Month 12	No
Secondary	Treatment Satisfaction		Month 12	No