Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch
* Drug: Placebo Patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZR-02-01 matrix fentanyl Patch<br>ZR-02-01 matrix fentanyl patch | Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch<br>* 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.<br>* Other names: ZR-02-01;|
| Placebo Comparator: Placebo Patch<br> | Drug: Placebo Patch<br>* 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<br>* Other names: Placebo Transdermal Matrix Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Chronic Pain, Osteoarthritis Pain, Osteoarthritis