Completed

NCT Number: NCT04683627

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

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

Completed

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Key information

Conditions

Osteoarthritis Pain of the Knee

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Applied Research Center of Arkansas, Little Rock, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac sodium active topical patch

Drug

A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.

Other names: HP-5000

Placebo Patch

Drug

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

Other names: Placebo

Primary outcomes

Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set)

Time frame: 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 outcomes

Change From Baseline to Week 12 in WOMAC Stiffness Score

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Noven Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A 12-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System (Patch) in Subjects With Osteoarthritis Pain of the Knee

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Dec 24, 2020
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.