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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP-5000 Treatment | Experimental | HP-5000 Topical Patch will be evaluated against placebo topical patches. |
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| Placebo Treatment | Placebo Comparator | Placebo patches without diclofenac sodium will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac sodium active topical patch | Drug | A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) | To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch 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 12. 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 ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Baseline and 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in WOMAC Stiffness Score | To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch 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 12. 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 ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Noven Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | United States | ||
| Clinical Research of West Florida,Inc. |
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Each participant contributed one study knee in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | HP-5000 Treatment | Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee |
| FG001 | Placebo Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2023 | Aug 15, 2025 |
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| Placebo patch | Drug | A placebo patch without diclofenac sodium was used for the placebo arm. |
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| 12 weeks |
| WOMAC Physical Function Change From Baseline at Week 12 | To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch 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 12. 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 ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Baseline and 12 weeks |
| Clearwater |
| Florida |
| 33765 |
| United States |
| Universal Axon Clinical Research, LLC | Doral | Florida | 33166 | United States |
| The Arthritis and Diabetes Clinic, Inc. | Monroe | Louisiana | 71203 | United States |
| Noven Pharmaceuticals, Inc. | Jersey City | New Jersey | 07310 | United States |
| Velocity Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Partners in Clinical Research | Cumberland | Rhode Island | 02864 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Quality Research Inc. | San Antonio | Texas | 78209 | United States |
Placebo topical patch
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HP-5000 Treatment | Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee |
| BG001 | Placebo Treatment | Placebo topical patch |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of OA of the knee | Mean | Standard Deviation | years |
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| BMI | Mean | Standard Deviation | Kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) | To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch 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 12. 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 ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-week |
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| Secondary | Change From Baseline to Week 12 in WOMAC Stiffness Score | To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch 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 12. 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 ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| Secondary | WOMAC Physical Function Change From Baseline at Week 12 | To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch 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 12. 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 ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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up to 13 weeks
The safety population includes all subjects who have at least 1 patch of double-blind study drug applied and who have a at least 1 post-dose safety measurement during the double-blind treatment phase.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HP-5000 Treatment | Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee | 0 | 184 | 0 | 184 | 33 | 184 |
| EG001 | Placebo Treatment | Placebo topical patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 12-week treatment. | 4 | 185 | 4 | 185 | 46 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| traumatic fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Application site dryness | General disorders | Systematic Assessment |
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| application site rash | General disorders | Systematic Assessment |
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| Application site swelling | General disorders | Systematic Assessment |
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| Application site vesicles | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Application site Bruise | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Covid-19 | Infections and infestations | Systematic Assessment |
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| Urinary tract Infection | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| Hpokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Kirshoff | Noven Pharmaceutical | 5512332668 | clinicaltrials@noven.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2023 | Aug 15, 2025 | SAP_003.pdf |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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