HALEON
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.
Pain
Voltaren Gel 1% (diclofenac sodium) (US only)
Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only)
Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only)
PHASE4
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 195 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | 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 |
Actual Study Start Date : | 2024-04-25 |
Estimated Primary Completion Date : | 2024-11-15 |
Estimated Study Completion Date : | 2024-11-15 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 40 Years to 85 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
RECRUITING
Quality Research Inc
Saint Anthony, Texas, United States, 78209
NOT YET RECRUITING
Vitamed Gałaj I Cichomski sp.j.
Bydgoszcz, Poland, 85-079
RECRUITING
Lux Med Medical Center.
Chojnice, Poland, 89-600
NOT YET RECRUITING
Silmedic sp. z o.o.
Katowice, Poland, 40-282
RECRUITING
Panaceum Research Center Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
Malbork, Poland, 82-200
NOT YET RECRUITING
Specialized Treatment and Research Center (SOL) Zbigniew Żęgota
Ostróda, Poland, 14-100
NOT YET RECRUITING
Santa Sp. z o. o. Santa Familia PTG Lodz
Łódź, Poland, 90-302