CClinicalTrials.gg
Sign In
CompletedNCT04683627Updated Sep 4, 2025Results posted

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

A Phase 3 interventional study of Diclofenac sodium active topical patch and Placebo patch in Osteoarthritis Pain of the Knee, sponsored by Noven Pharmaceuticals, Inc.. Completed at 10 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Noven Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Osteoarthritis Pain of the Knee
03

In context

Lead sponsor

Noven Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
370 participants (actual)

Study arms

  • Experimental
    HP-5000 Treatment

    HP-5000 Topical Patch will be evaluated against placebo topical patches.

    Drug: Diclofenac sodium active topical patch

  • Placebo comparator
    Placebo Treatment

    Placebo patches without diclofenac sodium will be used.

    Drug: Placebo patch

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.

    Also known as: HP-5000

  • DrugPlacebo patch

    A placebo patch without diclofenac sodium was used for the placebo arm.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Results

Posted Sep 4, 2025

Participant flow

Participant flow — Overall Study
MilestoneHP-5000 TreatmentPlacebo Treatment
Started184186
Completed184185
Not completed01

Outcome measures

PrimaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set)
score on a scaleHP-5000 TreatmentPlacebo Treatment
Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set)-4.6 ± 0.26-5.4 ± 0.26
SecondaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline to Week 12 in WOMAC Stiffness Score
score on a scaleHP-5000 TreatmentPlacebo Treatment
Change From Baseline to Week 12 in WOMAC Stiffness Score-1.6 ± 0.12-1.8 ± 0.12
SecondaryWOMAC 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
Reported as:
Mean · score on a scale
WOMAC Physical Function Change From Baseline at Week 12
score on a scaleHP-5000 TreatmentPlacebo Treatment
WOMAC Physical Function Change From Baseline at Week 12-13.3 ± 0.80-15.9 ± 0.89

Adverse events

Collected over up to 13 weeks. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HP-5000 Treatment0/184 (0%)0/184 (0%)33/184 (17.9%)
Placebo Treatment4/185 (2.2%)4/185 (2.2%)46/185 (24.9%)
Most frequent serious events
Most frequent serious events
EventHP-5000 TreatmentPlacebo Treatment
Atrial FibrillationCardiac disorders0/1841/185
vertigoEar and labyrinth disorders0/1841/185
FallInjury, poisoning and procedural complications0/1841/185
Spinal FractureInjury, poisoning and procedural complications0/1841/185
traumatic fractureInjury, poisoning and procedural complications0/1841/185
Most frequent other events
Showing 10 of 24
Most frequent other events
EventHP-5000 TreatmentPlacebo Treatment
Covid-19Infections and infestations4/1843/185
osteoarthritisMusculoskeletal and connective tissue disorders3/1844/185
Sinus bradycardiaCardiac disorders3/1842/185
Application site vesiclesGeneral disorders3/1840/185
Urinary tract InfectionInfections and infestations3/1843/185
ToothacheGastrointestinal disorders0/1843/185
application site rashGeneral disorders0/1843/185
Pain in extremityMusculoskeletal and connective tissue disorders1/1843/185
Neck painMusculoskeletal and connective tissue disorders0/1843/185
Atrioventricular block first degreeCardiac disorders2/1840/185

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)HP-5000 TreatmentPlacebo TreatmentTotal
<=18 years000
Between 18 and 65 years111120231
>=65 years7365138
Age, Continuous
Age, Continuous(years)HP-5000 TreatmentPlacebo TreatmentTotal
Mean62.2 ± 8.6261.4 ± 8.9461.8 ± 8.76
Sex: Female, Male
Sex: Female, Male(Participants)HP-5000 TreatmentPlacebo TreatmentTotal
Female119122241
Male6563128
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)HP-5000 TreatmentPlacebo TreatmentTotal
Hispanic or Latino5857115
Not Hispanic or Latino124128252
Unknown or Not Reported202
Race (NIH/OMB)
Race (NIH/OMB)(Participants)HP-5000 TreatmentPlacebo TreatmentTotal
American Indian or Alaska Native112
Asian292251
Native Hawaiian or Other Pacific Islander000
Black or African American302757
White124135259
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)HP-5000 TreatmentPlacebo TreatmentTotal
United States184185369
Duration of OA of the knee
Duration of OA of the knee(years)HP-5000 TreatmentPlacebo TreatmentTotal
Mean7.4 ± 6.428.7 ± 8.818.0 ± 7.73
BMI
BMI(Kg/m2)HP-5000 TreatmentPlacebo TreatmentTotal
Mean30.49 ± 5.00430.06 ± 5.16630.28 ± 5.083
08

Study locations

10 sites
  • Applied Research Center of Arkansas
    Little Rock, Arkansas 72212, United States
  • Clinical Research of West Florida,Inc.
    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
09

References and documents

Study documents

  • Study protocol · Feb 15, 2023
  • Statistical analysis plan · Feb 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04683627
Lead sponsor
Noven Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 24, 2020
Start date
Dec 29, 2020
Primary completion
Jul 18, 2022
Completion
Jul 25, 2022
Results posted
Sep 4, 2025
Last update
Sep 4, 2025

Study contacts

Study Director
study director · Noven Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Noven Pharmaceuticals, Inc.

Start the discussion