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

NCT04683627 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HP-5000-US-07
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 10

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

Conditions

Osteoarthritis Pain of the Knee

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 12-week

Secondary Outcomes (2)

• Change From Baseline to Week 12 in WOMAC Stiffness Score

  12 weeks

• WOMAC Physical Function Change From Baseline at Week 12

  Baseline and 12 weeks

Study Arms (2)

HP-5000 Treatment

EXPERIMENTAL

HP-5000 Topical Patch will be evaluated against placebo topical patches.

Drug: Diclofenac sodium active topical patch

Placebo Treatment

PLACEBO COMPARATOR

Placebo patches without diclofenac sodium will be used.

Drug: Placebo patch

Interventions

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.

Also known as: HP-5000

HP-5000 Treatment

Placebo patch DRUG

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

Also known as: Placebo

Placebo Treatment

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noven Pharmaceuticals, Inc.: lead

Study Sites (10)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Clinical Research of West Florida,Inc.

Clearwater, Florida, 33765, United States

Location

Universal Axon Clinical Research, LLC

Doral, Florida, 33166, United States

Location

The Arthritis and Diabetes Clinic, Inc.

Monroe, Louisiana, 71203, United States

Location

Noven Pharmaceuticals, Inc.

Jersey City, New Jersey, 07310, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Partners in Clinical Research

Cumberland, Rhode Island, 02864, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Results Point of Contact

• Title: Robert Kirshoff
• Organization: Noven Pharmaceutical

clinicaltrials@noven.com

5512332668

Study Officials

• Study Director

  Noven Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: December 29, 2020
• Primary Completion: July 18, 2022
• Study Completion: July 25, 2022
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)