A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee

Study Overview
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Brief Summary
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A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the Knee

Detailed Description
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This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase.

Official Title
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A 12-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System (Patch) in Subjects With Osteoarthritis Pain of the Knee

Conditions
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Osteoarthritis Pain of the Knee

Intervention / Treatment
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* Drug: Diclofenac sodium active topical patch
* Drug: Placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology criteria. Has an X-ray of the target knee, taken no more than 1 year before Baseline, showing evidence of OA. Has pain of OA in the designated/target study knee. Exclusion Criteria: Body mass index (BMI) > 40. Any subject who did not follow the restriction of prohibited therapies during Washout period. Arthritis of the target knee that is not caused by OA but caused by diseases such as rheumatoid arthritis, gout, psoriasis, syphilitic arthropathy, ochronosis, metabolic or other primary bone disease, or acute traumatic injury.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP-5000 Treatment<br>HP-5000 Topical Patch will be evaluated against placebo topical patches. | Drug: Diclofenac sodium active topical patch<br>* A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.<br>* Other names: HP-5000;|
| Placebo Comparator: Placebo Treatment<br>Placebo patches without diclofenac sodium will be used. | Drug: Placebo patch<br>* A placebo patch without diclofenac sodium was used for the placebo arm.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Osteoarthritis of the Knee pain score between Baseline and Week 12. Primary efficacy endpoint | Evaluate efficacy and safety of HP-5000 topical patches in subjects with OA of the knee by measuring change in Osteoarthritic pain score | 12-week vs. baseline |