Trial Outcomes & Findings for A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee (NCT NCT04683627)

Last Updated: 2025-09-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

370 participants

Primary outcome timeframe

Baseline and 12-week

Results posted on

2025-09-04

Participant Flow

Each participant contributed one study knee in this study.

Participant milestones

Participant milestones
Measure	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	Placebo Treatment Placebo topical patch
Overall Study STARTED	184	186
Overall Study COMPLETED	184	185
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HP-5000 Treatment n=184 Participants Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee	Placebo Treatment n=185 Participants Placebo topical patch	Total n=369 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
Age, Categorical Between 18 and 65 years	111 Participants n=5 Participants	120 Participants n=7 Participants	231 Participants n=5 Participants
Age, Categorical >=65 years	73 Participants n=5 Participants	65 Participants n=7 Participants	138 Participants n=5 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 8.62 • n=5 Participants	61.4 years STANDARD_DEVIATION 8.94 • n=7 Participants	61.8 years STANDARD_DEVIATION 8.76 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	122 Participants n=7 Participants	241 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	58 Participants n=5 Participants	57 Participants n=7 Participants	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=5 Participants	128 Participants n=7 Participants	252 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) White	124 Participants n=5 Participants	135 Participants n=7 Participants	259 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	184 participants n=5 Participants	185 participants n=7 Participants	369 participants n=5 Participants
Duration of OA of the knee	7.4 years STANDARD_DEVIATION 6.42 • n=5 Participants	8.7 years STANDARD_DEVIATION 8.81 • n=7 Participants	8.0 years STANDARD_DEVIATION 7.73 • n=5 Participants
BMI	30.49 Kg/m2 STANDARD_DEVIATION 5.004 • n=5 Participants	30.06 Kg/m2 STANDARD_DEVIATION 5.166 • n=7 Participants	30.28 Kg/m2 STANDARD_DEVIATION 5.083 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12-week

Outcome measures

Outcome measures
Measure	HP-5000 Treatment n=184 Participants Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee	Placebo Treatment n=185 Participants Placebo topical patch
Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set)	-4.6 score on a scale Standard Deviation 0.26	-5.4 score on a scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	HP-5000 Treatment n=184 Participants Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee	Placebo Treatment n=185 Participants Placebo topical patch
Change From Baseline to Week 12 in WOMAC Stiffness Score	-1.6 score on a scale Standard Deviation 0.12	-1.8 score on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Outcome measures
Measure	HP-5000 Treatment n=184 Participants Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee	Placebo Treatment n=185 Participants Placebo topical patch
WOMAC Physical Function Change From Baseline at Week 12	-13.3 score on a scale Standard Deviation 0.80	-15.9 score on a scale Standard Deviation 0.89

Adverse Events

HP-5000 Treatment

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 4 serious events

Other events: 46 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	HP-5000 Treatment n=184 participants at risk Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee	Placebo Treatment n=185 participants at risk Placebo topical patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 12-week treatment.
Cardiac disorders Atrial Fibrillation	0.00% 0/184 • 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.	0.54% 1/185 • 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.
Ear and labyrinth disorders vertigo	0.00% 0/184 • 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.	0.54% 1/185 • 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.
Injury, poisoning and procedural complications Fall	0.00% 0/184 • 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.	0.54% 1/185 • 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.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/184 • 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.	0.54% 1/185 • 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.
Injury, poisoning and procedural complications traumatic fracture	0.00% 0/184 • 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.	0.54% 1/185 • 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.

Other adverse events

Additional Information

Robert Kirshoff

Noven Pharmaceutical

Phone: 5512332668

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	HP-5000 Treatment n=184 participants at risk Diclofenac Sodium Active Topical Patch was evaluated against the placebo patch for 12-week for the treatment of OA pain of the knee	Placebo Treatment n=185 participants at risk Placebo topical patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 12-week treatment.
Blood and lymphatic system disorders Anemia	0.54% 1/184 • 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.	1.1% 2/185 • 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.
Cardiac disorders Sinus bradycardia	1.6% 3/184 • 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.	1.1% 2/185 • 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.
Cardiac disorders Atrioventricular block first degree	1.1% 2/184 • 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.	0.00% 0/185 • 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.
Gastrointestinal disorders Toothache	0.00% 0/184 • 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.	1.6% 3/185 • 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.
General disorders Application site dryness	0.54% 1/184 • 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.	1.1% 2/185 • 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.
General disorders application site rash	0.00% 0/184 • 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.	1.6% 3/185 • 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.
General disorders Application site swelling	0.54% 1/184 • 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.	1.1% 2/185 • 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.
General disorders Application site vesicles	1.6% 3/184 • 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.	0.00% 0/185 • 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.
General disorders Pain	1.1% 2/184 • 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.	0.54% 1/185 • 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.
General disorders Pyrexia	1.1% 2/184 • 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.	0.54% 1/185 • 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.
General disorders Application site Bruise	0.00% 0/184 • 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.	1.1% 2/185 • 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.
General disorders Fatigue	0.00% 0/184 • 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.	1.1% 2/185 • 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.
Infections and infestations Covid-19	2.2% 4/184 • 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.	1.6% 3/185 • 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.
Infections and infestations Urinary tract Infection	1.6% 3/184 • 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.	1.6% 3/185 • 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.
Infections and infestations Sinusitis	1.1% 2/184 • 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.	0.54% 1/185 • 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.
Infections and infestations Bronchitis	1.1% 2/184 • 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.	0.00% 0/185 • 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.
Infections and infestations Nasopharyngitis	0.00% 0/184 • 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.	1.1% 2/185 • 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.
Injury, poisoning and procedural complications Fall	0.54% 1/184 • 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.	1.1% 2/185 • 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.
Investigations Hepatic enzyme increased	1.1% 2/184 • 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.	0.54% 1/185 • 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.
Metabolism and nutrition disorders Hpokalaemia	0.00% 0/184 • 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.	1.1% 2/185 • 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.
Musculoskeletal and connective tissue disorders osteoarthritis	1.6% 3/184 • 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.	2.2% 4/185 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.54% 1/184 • 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.	1.6% 3/185 • 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.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/184 • 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.	1.6% 3/185 • 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.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/184 • 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.	1.1% 2/185 • 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.