2024-510839-22-00已完成4 期
A Prospective Real-World Evidence Study Evaluating the Effects of Voltaren use on Mobility and Quality of Life
Haleon CH S.a.r.l.6 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2024年7月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 6
- 主要终点
- 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).
研究概览
简要总结
• To evaluate the effects of Voltaren Gel on physical activity, measured through connected activity tracker.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Study Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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).
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).
次要结局
- Change from baseline on Days 7, 14, and 21 in daily Average number of steps taken
- Change from baseline on Days 7, 14, and 21 in daily Average number of stairs climbed/descended
- Change from baseline on Days 7, 14, and 21 in ratio of sedentary/non-sedentary time
- Change from baseline on Days 7, 14, and 21 in gait, assessed through speed and step irregularity
- 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)
研究者
Léa Floirac
Scientific
Haleon CH S.a.r.l.
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Measuring Outcomes With Validated ExerciseNCT07270185Boston University54
尚未招募
不适用
Acute Cardiovascular and Neuromuscular Responses to Walking With Blood Flow Restriction (BFR) in Older AdultsNCT07275138Universidade da Coruña20
进行中（未招募）
不适用
Activity and Cancer Survivorship Exercise PilotEndometrial CancerNCT07283029University of Iowa10
招募中
不适用
Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary IndividualsNCT07260747Istanbul Medipol University Hospital45
尚未招募
不适用
Mechanisms Underlying SGLT2i Kidney Effect in DKD ProgressionNCT07270198Mario Negri Institute for Pharmacological Research100