Osteoarthritis Pain of the Knee
Conditions
Brief summary
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
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.
Interventions
DRUGDiclofenac sodium active topical patch
A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.
DRUGPlacebo patch
A placebo patch without diclofenac sodium was used for the placebo arm.
Sponsors
Noven Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) | Baseline and 12-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in WOMAC Stiffness Score | 12 weeks | 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. |
| WOMAC Physical Function Change From Baseline at Week 12 | Baseline and 12 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Each participant contributed one study knee in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 184 |
| Placebo Treatment Placebo topical patch | 185 |
| Total | 369 |
Baseline characteristics
| Characteristic | Total | HP-5000 Treatment | Placebo Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 138 Participants | 73 Participants | 65 Participants |
| Age, Categorical Between 18 and 65 years | 231 Participants | 111 Participants | 120 Participants |
| Age, Continuous | 61.8 years STANDARD_DEVIATION 8.76 | 62.2 years STANDARD_DEVIATION 8.62 | 61.4 years STANDARD_DEVIATION 8.94 |
| BMI | 30.28 Kg/m2 STANDARD_DEVIATION 5.083 | 30.49 Kg/m2 STANDARD_DEVIATION 5.004 | 30.06 Kg/m2 STANDARD_DEVIATION 5.166 |
| Duration of OA of the knee | 8.0 years STANDARD_DEVIATION 7.73 | 7.4 years STANDARD_DEVIATION 6.42 | 8.7 years STANDARD_DEVIATION 8.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 115 Participants | 58 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 252 Participants | 124 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 51 Participants | 29 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants | 30 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 259 Participants | 124 Participants | 135 Participants |
| Region of Enrollment United States | 369 participants | 184 participants | 185 participants |
| Sex: Female, Male Female | 241 Participants | 119 Participants | 122 Participants |
| Sex: Female, Male Male | 128 Participants | 65 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 4 / 185 |
| other Total, other adverse events | 33 / 184 | 46 / 185 |
| serious Total, serious adverse events | 0 / 184 | 4 / 185 |
Outcome results
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.
Time frame: Baseline and 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HP-5000 Treatment | Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) | -4.6 score on a scale | Standard Deviation 0.26 |
| Placebo Treatment | Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) | -5.4 score on a scale | Standard Deviation 0.26 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HP-5000 Treatment | Change From Baseline to Week 12 in WOMAC Stiffness Score | -1.6 score on a scale | Standard Deviation 0.12 |
| Placebo Treatment | Change From Baseline to Week 12 in WOMAC Stiffness Score | -1.8 score on a scale | Standard Deviation 0.12 |
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HP-5000 Treatment | WOMAC Physical Function Change From Baseline at Week 12 | -13.3 score on a scale | Standard Deviation 0.8 |
| Placebo Treatment | WOMAC Physical Function Change From Baseline at Week 12 | -15.9 score on a scale | Standard Deviation 0.89 |