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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- HALEON
- 入组人数
- 196
- 试验地点
- 8
- 主要终点
- Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •Participant is male or female who, at the time of screening, is between the ages of 40 and 85 years, inclusive.
- •A participant who is willing and able to comply with scheduled visits, on-label Voltaren Gel use plan, and other study procedures.
- •A participant willing to wear Actigraph continuously 24/7 for the study period.
- •A participant in good general and mental health.
- •A participant with diagnosed knee mild/non-serious osteoarthritis, proven via radiological evidence collected within the last 3 years.
- •A participant with self-reported knee pain, with a score of greater than or equal to (>=) 40 millimeters (mm) less than or equal to (<=)70mm on the pain intensity visual analogue scale at the time of Informed Consent Form (ICF) signature.
- •A participant willing to use Voltaren Gel for up to 3 weeks.
排除标准
- •A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- •A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 1 month prior to study entry and/or during study participation.
- •A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- •A participant with confirmed rheumatologic disease
- •A participant who has experienced trauma to the knee within the last 2 months that resulted in pain and/or swelling.
- •A participant that has been administered local steroids or other Non-steroidal anti-inflammatory drugs (NSAIDs) injections to the knee within the last 3 months.
- •A participant with recent history of major knee injury or surgery.
- •A participant 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 participant with conditions not limited to the following: Gastrointestinal diseases, asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function, or liver disease as judged by investigator or Site Staff.
- •A participant diagnosed with other relevant medical conditions (example, psychiatric, neurological).
- •A participant who takes medication relating to above conditions, such as tricyclic antidepressants or anticonvulsants.
- •A participant with an active infection.
- •A participant who is pregnant, lactating, or plan to be pregnant or lactating during the study.
- •A participant with use of aspirin, Oral NSAIDs, topical treatment with any NSAIDs, warfarin, Angiotensin-converting enzyme (ACE) inhibitors, cyclosporine, diuretics, lithium or methotrexate, corticosteroids, or other anticoagulant therapy within 30 days of study.
- •A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients, including hypersensitivity to NSAIDs and aspirin triad.
- •A participant with any other acute or chronic illness that could compromise the integrity of study data or place the participant at risk by participating in the study.
- •A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
研究组 & 干预措施
Voltaren Gel
Participants will use Voltaren Gel 1 percent (%) (in the US) or Voltaren Gel 1.16% or Voltaren Gel 2.32% (in the EU) topically, applied daily as per label and leaflet instructions for up to 21 days. Participants will be instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
干预措施: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only) (Drug)
Voltaren Gel
Participants will use Voltaren Gel 1 percent (%) (in the US) or Voltaren Gel 1.16% or Voltaren Gel 2.32% (in the EU) topically, applied daily as per label and leaflet instructions for up to 21 days. Participants will be instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
干预措施: Voltaren Gel 1% (diclofenac sodium) (US only) (Drug)
Voltaren Gel
Participants will use Voltaren Gel 1 percent (%) (in the US) or Voltaren Gel 1.16% or Voltaren Gel 2.32% (in the EU) topically, applied daily as per label and leaflet instructions for up to 21 days. Participants will be instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
干预措施: Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only) (Drug)
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
时间窗: Baseline and Week 1
The average minutes of MVPA will be measured through a connected activity tracker (Actigraph device) worn by the participants. A mixed model with repeated measures (MMRM) will be used to analyse the change from baseline in MVPA average minutes as the response variable.
Change from Baseline in the Average Minutes of MVPA at Week 2
时间窗: Baseline and Week 2
The average minutes of MVPA will be measured through a connected activity tracker (Actigraph device) worn by the participants. A MMRM will be used to analyse the change from baseline in MVPA average minutes as the response variable.
Change from Baseline in the Average Minutes of MVPA at Week 3
时间窗: Baseline and Week 3
The average minutes of MVPA will be measured through a connected activity tracker (Actigraph device) worn by the participants. A MMRM will be used to analyse the change from baseline in MVPA average minutes as the response variable.
次要结局
- Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21(Baseline, Days 7, 14 and 21)
- Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS)(Baseline up to Day 21)
- Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21(Baseline, Days 7, 14 and 21)
- 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(Baseline, Days 7, 14 and 21)
- Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21(Baseline, Days 7, 14 and 21)
- Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21(Baseline, Days 7, 14 and 21)
- Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21(Baseline, Days 7, 14 and 21)
- WOMAC Physical Function Subscale Score on Days 7,14, and 21(Days 7, 14 and 21)
- Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain(Baseline, Days 7, 14 and 21)
- Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness(Baseline, Days 7, 14 and 21)
- Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21(Baseline, Days 7, 14 and 21)
- Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21(Baseline, Days 7, 14 and 21)
- MVPA on Each Day of the Study(Baseline up to Day 21)