A Prospective Real-World Evidence Study evaluating the effects of Voltaren use on Mobility and QoL of subjects with knee osteoarthritis (OA) pain.
- Conditions
- Mild/non-serious osteoarthritis (OA) of the knee.MedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2024-510839-22-00
- Lead Sponsor
- Haleon CH S.a.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 195
•A Subject between the age of 40 and 85 years., •A subject with diagnosed knee mild/non-serious osteoarthritis, proven via radiological evidence collected within the last 3 years., •A subject with self-reported knee pain, with a score of = 40 mm = 70mm on the pain intensity visual analogue scale at the Screening Visit., •A subject willing to use Voltaren Gel for up to 3 weeks.
•A subject with confirmed rheumatologic disease, •A subject who has experienced trauma to the knee within the last 2 months that resulted in pain and/or swelling., •A subject that has been administered local steroids or other NSAIDs injections to the knee within the last 3 months., •A subject with recent history of major knee injury or surgery., •A subject with knee skin area pathological condition which prevents application of product to the skins. Conditions such as: open skin wounds, infections, inflammations, or exfoliative dermatitis conditions., •A subject who is pregnant, lactating or plan to be pregnant or lactating during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To evaluate the effects of Voltaren Gel on physical activity, measured through connected activity tracker.;Secondary Objective: •To evaluate the effects of Voltaren Gel on functional mobility, measured through connected activity tracker., •To assess the functional mobility, measured through connected activity tracker, •To evaluate the effects of Voltaren Gel on functional mobility, measured through Subject related outcomes., •To evaluate the effects of Voltaren Gel on pain intensity., •To evaluate the effects of Voltaren Gel on activity-related pain and stiffness., •To evaluate the effects of Voltaren Gel on correlates of quality of life.;Primary end point(s): 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 Outcome Measures
Name Time Method Secondary end point(s):Change from baseline on Days 7, 14, and 21 in daily Average number of steps taken;Secondary end point(s):Change from baseline on Days 7, 14, and 21 in daily Average number of stairs climbed/descended;Secondary end point(s):Change from baseline on Days 7, 14, and 21 in ratio of sedentary/non-sedentary time;Secondary end point(s):Change from baseline on Days 7, 14, and 21 in gait, assessed through speed and step irregularity;Secondary end point(s):Change from baseline on Days 7, 14, and 21 in indices of morning stiffness (assessed through levels of mobility 30- and 60-mins post-wake)