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Nonsteroidal Anti-Inflammatory Drug

Voltaren Gel for Knee Osteoarthritis Pain

Phase 4

Waitlist Available

Research Sponsored by HALEON

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is male or female between the ages of 40 and 85 years

Participant with self-reported knee pain, with a score of >=40mm and <=70mm on the pain intensity visual analogue scale at the time of Informed Consent Form (ICF) signature

Must not have

Participant with knee skin area pathological condition preventing application of product to the skin

Participant with confirmed rheumatologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 7, 14 and 21

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see if using diclofenac gel on the skin can help people with knee osteoarthritis move better, be more active, and improve their overall quality of life including sleep

Who is the study for?

This trial is for men and women aged 40-85 with mild to moderate knee pain from osteoarthritis, scoring 40-70mm on a pain scale. Participants must be willing to use Voltaren Gel as directed, wear an activity tracker continuously, and have radiological proof of osteoarthritis within the last three years.

What is being tested?

The study tests how different concentrations of Voltaren Gel (diclofenac) affect mobility and quality of life in those with knee osteoarthritis. It measures improvements in movement, sleep, mood, and daily activities.

What are the potential side effects?

Voltaren Gel may cause side effects like skin irritation at the application site, digestive issues such as nausea or indigestion, liver function changes, kidney problems or increased blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 85 years old.

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I have knee pain rated between 40mm and 70mm on a pain scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot apply products to my knee due to a skin condition.

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I have been diagnosed with a rheumatic disease.

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I currently have an active infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 7, 14 and 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 7, 14 and 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7, 14 and 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in the Average Minutes of MVPA at Week 2

Change from Baseline in the Average Minutes of MVPA at Week 3

Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1

Secondary study objectives

Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21

Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21

Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21

+10 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Voltaren GelExperimental Treatment3 Interventions

Participants will use Voltaren Gel 1 percent (%) (in the US) or Voltaren Gel 1.16% or Voltaren Gel 2.32% (in the EU) topically, applied daily as per label and leaflet instructions for up to 21 days. Participants will be instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Voltaren Gel 1% (diclofenac sodium) (US only)

2024

Completed Phase 4

~200

Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only)

2024

Completed Phase 4

~200