Pain
Conditions
Keywords
Pain, Chronic Pain, Osteoarthritis Pain, Osteoarthritis
Brief summary
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
Detailed description
This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.
Interventions
DRUGZR-02-01 Fentanyl Transdermal Matrix Patch
Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.
DRUGPlacebo Patch
Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period
Sponsors
ZARS Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.
Exclusion criteria
* Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Knee and Hip Osteoarthritis Index | 12 weeks | The Pain,Stiffness and Physical Function subscales of the WOMAC Knee and Hip Osteoarthritis Index (5-point Likert scale: none through extreme) was employed. The subscales consist of 24 questions (5 pain, 2 stiffness and 17 physical function) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 12 weeks | — |
| TOPS survey | 12 weeks | To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health |
Countries
United States
Outcome results
None listed