protocolSection identificationModule nctId: NCT06379893, orgStudyIdInfo id: 300128, secondaryIdInfos id: 2024-510839-22-00, type: CTIS, briefTitle: A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: HALEON, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 195, type: ESTIMATED, armsInterventionsModule interventions name: Voltaren Gel 1% (diclofenac sodium) (US only), interventions name: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only), interventions name: Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only), outcomesModule primaryOutcomes measure: Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1, primaryOutcomes measure: Change from Baseline in the Average Minutes of MVPA at Week 2, primaryOutcomes measure: Change from Baseline in the Average Minutes of MVPA at Week 3, secondaryOutcomes measure: Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21, secondaryOutcomes measure: MVPA on Each Day of the Study, secondaryOutcomes measure: WOMAC Physical Function Subscale Score on Days 7,14, and 21, secondaryOutcomes measure: Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS), secondaryOutcomes measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain, secondaryOutcomes measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness, secondaryOutcomes measure: Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21, secondaryOutcomes measure: Change from Baseline in Health-related Quality of Life Assessed Using European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire on Days 7, 14, and 21, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False