Back to resultsOxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
Primary Purpose
Chronic Pain, Neuropathic Pain, Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oxymorphone Extended Release
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Cancer Pain, Neuropathic Pain, Extended Release, Long-Acting Opioid, Oxymorphone
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:
- 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Tolerability
Secondary Outcome Measures
Average daily pain intensity (Question 5 of BPI)
Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
Average daily dose of oxymorphone ER
Average daily dose of rescue medication
Total daily dose of oxymorphone ER and rescue medication
Time to stabilization
Patient/investigator global assessment of pain relief
Treatment Satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00911261
Brief Title
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
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Neuropathic Pain, Cancer
Keywords
Cancer Pain, Neuropathic Pain, Extended Release, Long-Acting Opioid, Oxymorphone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxymorphone Extended Release
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Average daily pain intensity (Question 5 of BPI)
Time Frame
Week 1-4, Month 12
Title
Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
Time Frame
Week 1-4, Month 12
Title
Average daily dose of oxymorphone ER
Time Frame
Daily
Title
Average daily dose of rescue medication
Time Frame
Daily
Title
Total daily dose of oxymorphone ER and rescue medication
Time Frame
Daily
Title
Time to stabilization
Time Frame
Month 12
Title
Patient/investigator global assessment of pain relief
Time Frame
Month 12
Title
Treatment Satisfaction
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
We'll reach out to this number within 24 hrs