Osteoarthritis
Conditions
Keywords
Osteoarthritis, chronic pain, opioid, transdermal
Brief summary
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.
Detailed description
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Interventions
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee. * receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
Exclusion criteria
* receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products * scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics. Other protocol-specific exclusion/inclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who were treated successfully for pain management | — |
| a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to early discontinuation due to lack of efficacy | — |
| Dose level at end of titration | — |
| Average pain intensity and patient satisfaction scores | — |
| Diary pain scores | — |
| Investigator's assessment of therapeutic response | — |
| Incidence of early discontinuation due to lack of efficacy | — |
Countries
United States
Outcome results
None listed