Trial Outcomes & Findings for A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis (NCT NCT03277066)
NCT ID: NCT03277066
Last Updated: 2021-12-23
Results Overview
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.
COMPLETED
PHASE2
289 participants
Baseline and 4 weeks
2021-12-23
Participant Flow
Participant milestones
| Measure |
Diclofenac Sodium Active Topical Patch 1
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Placebo Patch
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
72
|
146
|
|
Overall Study
COMPLETED
|
69
|
71
|
143
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
HP-5000-75α Patch (5% Diclofenac Sodium)
n=69 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s for 4-week treatment.
|
HP-5000-DRS400 Patch (5% Diclofenac Sodium)
n=71 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Placebo Patch
n=143 Participants
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 8.65 • n=7 Participants
|
59 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 8.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
|
BMI
|
29.51 kg/m^2
STANDARD_DEVIATION 5.103 • n=5 Participants
|
29.83 kg/m^2
STANDARD_DEVIATION 4.898 • n=7 Participants
|
29.89 kg/m^2
STANDARD_DEVIATION 5.257 • n=5 Participants
|
29.78 kg/m^2
STANDARD_DEVIATION 5.116 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksTo 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.
Outcome measures
| Measure |
Placebo Patch
n=143 Participants
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 1
n=69 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
n=71 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score
|
-5.2 score on a scale
Standard Deviation 4.16
|
-6.3 score on a scale
Standard Deviation 4.47
|
-5.6 score on a scale
Standard Deviation 4.06
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksTo 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.
Outcome measures
| Measure |
Placebo Patch
n=138 Participants
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 1
n=68 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
n=68 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
WOMAC Pain Score Week 2 Change From Baseline
|
-5.0 score on a scale
Standard Deviation 4.01
|
-5.8 score on a scale
Standard Deviation 4.29
|
-5.3 score on a scale
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksTo 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.
Outcome measures
| Measure |
Placebo Patch
n=135 Participants
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 1
n=67 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
n=67 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
WOMAC Stiffness Score Change From Baseline
|
-1.7 score on a scale
Standard Deviation 1.77
|
-2.4 score on a scale
Standard Deviation 2.06
|
-2.1 score on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksTo 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.
Outcome measures
| Measure |
Placebo Patch
n=143 Participants
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 1
n=69 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
n=71 Participants
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
WOMAC Physical Function Score
|
-15.6 score on a scale
Standard Deviation 13.07
|
-19.8 score on a scale
Standard Deviation 14.85
|
-19.3 score on a scale
Standard Deviation 13.63
|
Adverse Events
Diclofenac Sodium Active Topical Patch 1
Diclofenac Sodium Active Topical Patch 2
Placebo Patch
Serious adverse events
| Measure |
Diclofenac Sodium Active Topical Patch 1
n=69 participants at risk
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
n=71 participants at risk
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Placebo Patch
n=143 participants at risk
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/69 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
Other adverse events
| Measure |
Diclofenac Sodium Active Topical Patch 1
n=69 participants at risk
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Diclofenac Sodium Active Topical Patch 2
n=71 participants at risk
Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.
Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
Placebo Patch
n=143 participants at risk
Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
|
|---|---|---|---|
|
General disorders
Product taste abnormal
|
0.00%
0/69 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
General disorders
Asthenia
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
General disorders
Chest pain
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/69 • Number of events 1 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/69 • Number of events 1 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
1.4%
2/143 • Number of events 2 • 4 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/69 • 4 weeks
|
2.8%
2/71 • Number of events 2 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.9%
2/69 • Number of events 2 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Bronchitis
|
1.4%
1/69 • Number of events 1 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Infections and infestations
Laryngitis
|
1.4%
1/69 • Number of events 1 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/69 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/69 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.4%
1/69 • Number of events 3 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.4%
1/69 • Number of events 1 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/69 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/69 • Number of events 1 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/69 • 4 weeks
|
1.4%
1/71 • Number of events 1 • 4 weeks
|
0.00%
0/143 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
1.4%
2/143 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/69 • 4 weeks
|
0.00%
0/71 • 4 weeks
|
0.70%
1/143 • Number of events 1 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place