NCT06379893

A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain

A Prospective Real-World Evidence Study Evaluating the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis (OA) Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA.

Detailed description

This prospective open-label, single-arm, multi-country (United States \[US\] and European Union \[EU\]) real-world evidence study will be conducted in a hybrid form and will focus on assessing the impact of Voltaren Gel on functional mobility and QoL in individuals with mild/nonserious OA of the knee. Participants will be required to be physically present at the study site for screening, end of baseline and end of study visits. The remaining treatment will be conducted in a remote manner (for example, at home) to observe the real-world usage of Voltaren Gel. This study will utilize a research-grade validated wearable device: Actigraph, to accurately measure objective changes in functional mobility. Sufficient participants will be screened to enroll approximately 195 participants to ensure that around 147 of these participants will successfully complete the entire study.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Voltaren Gel	Diclofenac sodium gel in 3 different concentrations as- Diclofenac sodium 1%, 1.16% and 2.32% whichever was available in the given region.

Timeline

• Start date: 2024-04-25
• Primary completion: 2024-10-29
• Completion: 2024-10-29
• First posted: 2024-04-23
• Last updated: 2026-01-20
• Results posted: 2026-01-20

Locations

8 sites across 2 countries: United States, Poland