A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis

Study Overview
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Brief Summary
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A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee

Detailed Description
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This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.

Official Title
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A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis (OA) of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Diclofenac Sodium Active Topical Patch 1
* Drug: Diclofenac Sodium Active Topical Patch 2
* 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 (ACR) criteria, including: Symptoms for at least 6 months prior to screening, AND Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed. Exclusion Criteria: Body mass index (BMI) > 40 Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period. Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).

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: Diclofenac Sodium Active Topical Patch 1<br>Diclofenac sodium 1 topical patches will be compared against placebo patches. | Drug: Diclofenac Sodium Active Topical Patch 1<br>* HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)<br>* Other names: HP-5000;Drug: Placebo patch<br>* Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)<br>* Other names: Placebo treatment;|
| Experimental: Diclofenac Sodium Active Topical Patch 2<br>Diclofenac sodium 2 topical patches will be compared against placebo patches. | Drug: Diclofenac Sodium Active Topical Patch 2<br>* HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)<br>* Other names: HP-5000;Drug: Placebo patch<br>* Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)<br>* Other names: Placebo treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score | To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Pain Score Week 2 Change From Baseline | To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Baseline and 2 weeks | 
| WOMAC Stiffness Score Change From Baseline | To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome. | Baseline and 4 weeks | 
| WOMAC Physical Function Score | To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome. | Baseline and 4 weeks |