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The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZR-02-01 matrix fentanyl Patch | Experimental | ZR-02-01 matrix fentanyl patch |
|
| Placebo Patch | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZR-02-01 Fentanyl Transdermal Matrix Patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Knee and Hip Osteoarthritis Index | 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) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 12 weeks | |
| TOPS survey | To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Farmer, Jr, MD | Radiant Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Reserach Center | Phoenix | Arizona | 85023 | United States | ||
| Redpoint Research |
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|
| Placebo Patch | Drug | 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 |
|
|
| Phoenix |
| Arizona |
| 85029 |
| United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92101 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Boling Clinical Trials | Upland | California | 91786 | United States |
| Radiant Research | Daytona Beach | Florida | 32114 | United States |
| Ocala Rheumatology | Ocala | Florida | 34474 | United States |
| Tampa Medical Group | Tampa | Florida | 33614 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| Pain Trials Center - Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Phase III Clinical Trials | Fall River | Massachusetts | 02720 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Analgesic Development Ltd. | New York | New York | 10022 | United States |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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