A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain
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.
Timeline
- Start
- 2024-04-25
- Primary completion
- 2024-10-29
- Completion
- 2024-10-29
Outcome
Mixed primary results
registry A positive change from Baseline indicated improvement. NCT06379893 ↗
registry analysis (superiority test); Voltaren Gel; p <0.001; Least Square Means 15.6 (95% CI 8.3 to 22.8); MMRM NCT06379893 ↗
registry analysis (superiority test); Voltaren Gel; p = 0.001; Least Square Means 13 (95% CI 5.2 to 20.9); MMRM NCT06379893 ↗
registry analysis (superiority test); Voltaren Gel; p = 0.653; Least Square Means 2.1 (95% CI -7.1 to 11.3); MMRM NCT06379893 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 1 % | Topical |
| Subject | Diclofenac | Other / unclassified | 1.16 % | Topical |
| Subject | Diclofenac | Other / unclassified | 2.32 % | Topical |
Indications
No indication recorded.