Phase 2
Completed N=289
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Source: ClinicalTrials.gov NCT03277066 ↗Enrolled (actual)
289
Serious AEs
0.7%
Results posted
Dec 2021
Primary outcomePrimary: Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score — -6.3; -5.6; -5.2 score on a scale — p=0.0110
Summary
A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score |
-6.3; -5.6; -5.2 | 0.0110 sig |
| SECONDARY WOMAC Pain Score Week 2 Change From Baseline |
-5.8; -5.3; -5.0 | — |
| SECONDARY WOMAC Stiffness Score Change From Baseline |
-2.4; -2.1; -1.7 | — |
| SECONDARY WOMAC Physical Function Score |
-19.8; -19.3; -15.6 | — |
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 (ACR) criteria, including:
- Symptoms for at least 6 months prior to screening, AND
- Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
- The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.
Exclusion Criteria
- Body mass index (BMI) > 40
- Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.
- Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
Data sourced from ClinicalTrials.gov (NCT03277066). 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. Informational only — not medical advice.