Phase 3
N=370
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
Osteoarthritis Pain of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT04683627 ↗Enrolled (actual)
370
Serious AEs
1.1%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) — -4.6; -5.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diclofenac sodium active topical patch (Drug); Placebo patch (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Noven Pharmaceuticals, Inc.
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) |
-4.6; -5.4 | — |
| SECONDARY Change From Baseline to Week 12 in WOMAC Stiffness Score |
-1.6; -1.8 | — |
| SECONDARY WOMAC Physical Function Change From Baseline at Week 12 |
-13.3; -15.9 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04683627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.