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

Phase 3

Completed

Interventions: Drug: Diclofenac sodium active topical patch
Drug: Placebo patch

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

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.

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
The change in Osteoarthritis of the Knee pain score between Baseline and Week 12. Primary efficacy endpoint	12-week vs. baseline	Evaluate efficacy and safety of HP-5000 topical patches in subjects with OA of the knee by measuring change in Osteoarthritic pain score

Secondary Outcome Measures

Name	Time	Method

Locations (10): Noven Pharmaceuticals, Inc.
🇺🇸
Jersey City, New Jersey, United States
Partners in Clinical Research
🇺🇸
Cumberland, Rhode Island, United States
Palmetto Clinical Research
🇺🇸
Summerville, South Carolina, United States
Applied Research Center of Arkansas
🇺🇸
Little Rock, Arkansas, United States
Clinical Research of West Florida,Inc.
🇺🇸
Clearwater, Florida, United States
Metroplex Clinical Research Center
🇺🇸
Dallas, Texas, United States
Quality Research Inc.
🇺🇸
San Antonio, Texas, United States
Universal Axon Clinical Research, LLC
🇺🇸
Doral, Florida, United States
Velocity Clinical Research
🇺🇸
Cincinnati, Ohio, United States
The Arthritis and Diabetes Clinic, Inc.
🇺🇸
Monroe, Louisiana, United States