Evaluation of Diclofenac Diethylamine Gel on Mobility and Quality of Life in Patients with Mild Knee Osteoarthritis: A Prospective Real-World Study

The primary objective of this study is to evaluate the effects of **Voltaren Gel** on physical activity in individuals with mild/non-serious **osteoarthritis** of the knee. This is measured through a connected activity tracker. Understanding the impact of Voltaren Gel on physical activity is clinically relevant as it may provide insights into its efficacy in improving mobility and managing symptoms associated with knee osteoarthritis, potentially enhancing patient quality of life.

Secondary objectives include:

• Evaluating the effects of Voltaren Gel on functional mobility, measured through a connected activity tracker.
• Assessing functional mobility through subject-related outcomes.
• Evaluating the effects of Voltaren Gel on pain intensity.
• Evaluating the effects on activity-related pain and stiffness.
• Evaluating the effects on correlates of quality of life.

The clinical trial involves a total of **30 participants** diagnosed with mild/non-serious **osteoarthritis** of the knee. The study population includes both male and female subjects, aged between 40 and 85 years. Participants were selected based on specific criteria, including a radiological diagnosis of knee osteoarthritis within the last three years and self-reported knee pain with a score between 40 mm and 70 mm on the pain intensity visual analogue scale. The trial does not exclude vulnerable populations. Participants are required to be willing to use Voltaren Gel for up to three weeks. The study aims to evaluate the effects of Voltaren Gel on physical activity, which will be measured through a connected activity tracker. Lifestyle considerations such as diet and physical activity levels are not specified in the available data.

The clinical trial is designed as a **prospective, open-label, single-arm, multi-country** study, focusing on the effects of Voltaren Gel on functional mobility and quality of life in subjects with mild/non-serious **osteoarthritis** of the knee. The trial will involve participants aged between 40 and 85 years, who have been diagnosed with knee osteoarthritis, confirmed by radiological evidence within the last three years. Participants must report knee pain with a score between 40 mm and 70 mm on the pain intensity visual analogue scale at the screening visit and be willing to use Voltaren Gel for up to three weeks.

The trial will commence with a screening visit to confirm eligibility based on the inclusion criteria. Following the screening, participants will be enrolled in the study and will begin using the investigational product, Voltaren Gel, for a maximum treatment period of 21 days. The primary endpoint is the change from baseline in the average minutes of moderate and vigorous physical activity at weeks 1, 2, and 3. Secondary endpoints include changes from baseline in daily average steps taken, stairs climbed/descended, the ratio of sedentary/non-sedentary time, gait assessed through speed and step irregularity, and indices of morning stiffness.

Participants will be required to attend follow-up visits on days 7, 14, and 21 to assess the primary and secondary endpoints. These visits will involve the collection of data on physical activity and mobility, using connected activity trackers. The end-of-study visit will occur at the conclusion of the 21-day treatment period, where final assessments will be conducted to evaluate the overall impact of the treatment.

The expected duration of participant involvement is approximately three weeks, with the trial estimated to end by November 8, 2024. Conditions that may lead to early termination from the study include adverse reactions to the treatment or withdrawal of consent by the participant. The study aims to provide real-world evidence on the effectiveness of Voltaren Gel in improving mobility and quality of life in individuals with knee osteoarthritis.

The clinical trial involves the use of two experimental medications, both containing the active substance **diclofenac diethylamine**. The first medication, Voltaren SPORT, is formulated as a gel with a concentration of 11.6 mg/g. It is intended for **topical application** and is administered directly to the skin. The maximum daily dose is 16 grams, with a total maximum dose of 336 grams over a treatment period of up to 3 days. This formulation is not a paediatric formulation and is classified under the ATC code M02AA15, indicating its use as an anti-inflammatory and analgesic agent.

The second experimental medication, Voltaren MAX, is also a gel but with a higher concentration of 23.2 mg/g. It is designed for **cutaneous use**, meaning it is applied to the skin surface. The maximum daily dose for this formulation is 40 milligrams, with a total maximum dose of 820 milligrams over a treatment period of up to 21 days. Similar to Voltaren SPORT, this formulation is not intended for paediatric use and shares the same ATC classification, M02AA15. Both formulations are produced by HALEON POLAND SP. Z O.O. and are chemically derived.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are mentioned. The trial aims to evaluate the effects of Voltaren Gel on physical activity, as measured through a connected activity tracker. Participant compliance with the dosing schedule will be monitored to ensure adherence to the prescribed treatment regimen.

Efficacy in this clinical trial will be assessed by evaluating the effects of Voltaren Gel on physical activity and quality of life in subjects with mild to non-serious **osteoarthritis** of the knee. The primary endpoint is the change from baseline in the average minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 (days 1-7), Week 2 (days 8-14), and Week 3 (days 15-21). Secondary endpoints include changes from baseline on Days 7, 14, and 21 in the daily average number of steps taken, the daily average number of stairs climbed/descended, the ratio of sedentary/non-sedentary time, gait assessed through speed and step irregularity, and indices of morning stiffness assessed through levels of mobility 30- and 60-minutes post-wake.

The efficacy parameters will be measured using a connected activity tracker, which will provide objective data on physical activity levels. Data collection will occur at specified time points throughout the trial, allowing for a comprehensive analysis of changes in physical activity and mobility. The trial is designed as a prospective, open-label, single-arm, multi-country real-world evidence study, ensuring that the results reflect the effects of Voltaren Gel in a real-world setting. The study will include subjects aged 40 to 85 years with diagnosed knee osteoarthritis, confirmed via radiological evidence collected within the last three years, and self-reported knee pain with a specific score on the pain intensity visual analogue scale.