A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain
- Registration Number
- NCT06379893
- Lead Sponsor
- HALEON
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Voltaren Gel Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only) 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. Voltaren Gel Voltaren Gel 1% (diclofenac sodium) (US only) 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. Voltaren Gel Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only) 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 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 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 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21 Baseline, Days 7, 14 and 21 Daily average number of steps taken will be measured through a connected activity tracker (Actigraph device) worn by the participants. Change from baseline in daily average number of steps taken will be analysed using MMRM.
Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) Baseline up to Day 21 Participants will rate the pain intensity experienced by them daily within the eDiary, using NRS. NRS is an 11-point scale with scores ranging from 0 to 10 where score 0 = no pain, 1 = slight pain, 2-3 = mild pain, 4-6 = moderate pain, 7 = severe pain, 8 to 9 = extreme pain, 10=pain as bad as it could be. Higher scores indicate greater pain intensity. Change from Baseline in self-reported pain intensity will be analysed using MMRM.
Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21 Baseline, Days 7, 14 and 21 Participants will rate how sleepy or alert they are feeling using Karolinska Sleepiness Scale. The scale ranges from 1 to 9 where 1 = extremely alert, 2 = very alert, 3 = alert, 4 = fairly alert, 5 = neither alert nor sleepy, 6 = some signs of sleepiness, 7 = sleepy, but no efforts to keep alert, 8 = sleepy, some efforts to keep alert, 9 = very sleepy, great effort to keep alert, fighting sleep. Higher scores indicate greater sleepiness. Change from Baseline will be calculated as score at indicated post-Baseline timepoint minus score at Baseline.
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 Health-related quality of life of participants will be assessed using the EQ-5D-5L questionnaire. It consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with 5 response levels for each dimension where Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, Level 5 = unable to perform activities/extreme problems. Participants will be asked to indicate their health by ticking the box next to the most appropriate response level for each dimension. The response levels will be used to derive a health index score ranging from less than 0 (worst imaginable health) to 1 (best imaginable health) where higher scores indicate better health. Change from Baseline will be calculated as score at indicated post-Baseline timepoint minus score at Baseline.
Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21 Baseline, Days 7, 14 and 21 Gait will be assessed through speed and step irregularity measurements using a connected activity tracker (Actigraph device) worn by the participants. Change from baseline in gait will be analysed using MMRM.
Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21 Baseline, Days 7, 14 and 21 Indices of morning stiffness will be assessed through levels of mobility 30 and 60-mins post-wake. Functional mobility will be measured through a connected activity tracker (Actigraph device) worn by the participants. Change from baseline in indices of morning stiffness will be analysed using MMRM.
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 Participants will complete the WOMAC questionnaire daily using eDiary. The WOMAC questionnaire consists of 24 questions categorised in 3 subscales - Pain, Stiffness, Physical function. Each subscale is scored on a 5-point Likert scale where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. Total score ranges from 0 to 96 with 0 being the best and 96 being the worst. The physical function subscale consists of 17 questions related to level of difficulty in performing functions, on average, during the last 48 hours. The total score for physical function subscale ranges from 0 to 68. Higher scores indicate more difficulty in performing physical functions. Change from baseline in WOMAC physical function subscale score will be analysed using MMRM.
WOMAC Physical Function Subscale Score on Days 7,14, and 21 Days 7, 14 and 21 Physical function subscale score of the WOMAC questionnaire will be used to study participant's perceived ability to exercise more regularly. It consists of 17 questions related to level of difficulty in performing functions, on average, during the last 48 hours. Participants will score the questions on a 5-point Likert scale daily using eDiary where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total score for physical function subscale ranges from 0 to 68. Higher scores indicate more difficulty in performing physical functions.
Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain Baseline, Days 7, 14 and 21 The pain subscale of the WOMAC questionnaire consists of 5 questions related to severity of pain experienced by the participant when walking, stair climbing, at night, at rest, weightbearing, on average, during the last 48 hours. Participants will score the questions on a 5-point Likert scale daily using eDiary where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total score for pain subscale ranges from 0 to 20. Higher scores indicate extreme pain. Change from baseline in WOMAC pain subscale score will be analysed using MMRM.
Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness Baseline, Days 7, 14 and 21 The stiffness subscale of the WOMAC questionnaire consists of 2 questions related to severity of stiffness experienced by the participant at morning and during the day, on average, during the last 48 hours. Participants will score the questions on a 5-point Likert scale daily using eDiary, where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total score for stiffness subscale ranges from 0 to 8. Higher scores indicate extreme stiffness. Change from baseline in WOMAC stiffness subscale score will be analysed using MMRM.
Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21 Baseline, Days 7, 14 and 21 Daily average number of stairs climbed/descended will be measured through a connected activity tracker (Actigraph device) worn by the participants. Change from baseline in daily average number of stairs climbed/descended will be analysed using MMRM.
Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21 Baseline, Days 7, 14 and 21 Ratio of sedentary/non-sedentary time will be measured through a connected activity tracker (Actigraph device) worn by the participants. Change from baseline in ratio of sedentary/non-sedentary time will be analysed using MMRM.
MVPA on Each Day of the Study Baseline up to Day 21 The average minutes of MVPA will be measured through a connected activity tracker (Actigraph device) worn by the participants.
Trial Locations
- Locations (8)
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
馃嚨馃嚤Malbork, Poland
Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew 呕臋gota
馃嚨馃嚤Ostr贸da, Poland
Santa Sp. z o.o. Santa Familia PTG Lodz
馃嚨馃嚤艁贸d藕, Poland
Silmedic sp. z o.o.
馃嚨馃嚤Katowice, Poland
Tandem Clinical Research
馃嚭馃嚫Marrero, Louisiana, United States
Quality Research Inc
馃嚭馃嚫San Antonio, Texas, United States
Vitamed Ga艂aj I Cichomski sp.j.
馃嚨馃嚤Bydgoszcz, Poland
Centrum Medyczne Lukamed.
馃嚨馃嚤Chojnice, Poland