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New patch could ease arthritic knee pain without a pill

NCT ID NCT04683627

Symptom relief Sponsor: Noven Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a medicated patch (HP-5000) containing diclofenac sodium against a placebo patch in 370 adults with osteoarthritis knee pain. For 12 weeks, participants wore the patch on their knee to see if it reduced pain and stiffness better than a dummy patch. The goal is to provide a simple, topical option for managing osteoarthritis symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diclofenac sodium topical patch
What this could lead to
If it works, this patch could offer a convenient, non-pill option to reduce knee pain and stiffness from osteoarthritis.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The patch may not work better than a placebo, and some people may have skin irritation or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

370 people

The number who actually took part.

Started

Dec 2020

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis pain of the knee

Contacts and locations

Locations

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212, United States

  • Clinical Research of West Florida,Inc.

    Clearwater, Florida, 33765, United States

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231, United States

  • Noven Pharmaceuticals, Inc.

    Jersey City, New Jersey, 07310, United States

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485, United States

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864, United States

  • Quality Research Inc.

    San Antonio, Texas, 78209, United States

  • The Arthritis and Diabetes Clinic, Inc.

    Monroe, Louisiana, 71203, United States

  • Universal Axon Clinical Research, LLC

    Doral, Florida, 33166, United States

  • Velocity Clinical Research

    Cincinnati, Ohio, 45242, United States