Back to resultsOpen-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Primary Purpose
Cancers, Pain, Lower Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxymorphone ER
Sponsored by
About this trial
This is an interventional treatment trial for Cancers, Pain
Eligibility Criteria
Inclusion Criteria:
- The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.
- Males or females, age 18 and 75 years, inclusively.
- The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.
Exclusion Criteria:
- The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.
- The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.
- Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.
Sites / Locations
- Arizona Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxymorphone ER
Arm Description
Outcomes
Primary Outcome Measures
Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER
Secondary Outcome Measures
To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00904280
Brief Title
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Official Title
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancers, Pain, Lower Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxymorphone ER
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxymorphone ER
Intervention Description
Open label
Primary Outcome Measure Information:
Title
Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER
Time Frame
1 year study
Secondary Outcome Measure Information:
Title
To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain
Time Frame
1 year study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.
Males or females, age 18 and 75 years, inclusively.
The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.
Exclusion Criteria:
The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.
The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.
Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Director
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
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