A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
- Conditions
- Osteoarthritis Pain of the Knee
- Interventions
- Drug: Placebo patch
- Registration Number
- NCT04683627
- Lead Sponsor
- Noven Pharmaceuticals, Inc.
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HP-5000 Treatment Diclofenac sodium active topical patch HP-5000 Topical Patch will be evaluated against placebo topical patches. Placebo Treatment Placebo patch Placebo patches without diclofenac sodium will be used.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set) Baseline and 12-week 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 12 in WOMAC Stiffness Score 12 weeks 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.
WOMAC Physical Function Change From Baseline at Week 12 Baseline and 12 weeks 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.
Trial Locations
- Locations (10)
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Clinical Research of West Florida,Inc.
🇺🇸Clearwater, Florida, United States
Universal Axon Clinical Research, LLC
🇺🇸Doral, Florida, United States
The Arthritis and Diabetes Clinic, Inc.
🇺🇸Monroe, Louisiana, United States
Noven Pharmaceuticals, Inc.
🇺🇸Jersey City, New Jersey, United States
Velocity Clinical Research
🇺🇸Cincinnati, Ohio, United States
Partners in Clinical Research
🇺🇸Cumberland, Rhode Island, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
Applied Research Center of Arkansas🇺🇸Little Rock, Arkansas, United States