A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379893
• Other study ID #: 300128
• Secondary ID: 2024-510839-22-0
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2024
• Source: HALEON
• Contact: Haleon Response Center
• Phone: +441932959500
• Email: ww.clinical-trial-register[@]haleon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• Voltaren Gel 1% (diclofenac sodium) (US only)
Participants in the US will use Volatren Gel containing 1% diclofenac sodium.
• Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only)
Participants in the EU will use Volatren Gel containing 1.16% diclofenac diethylammonium.
• Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only)
Participants in the EU will use Volatren Gel containing 2.32% diclofenac diethylammonium.

Locations

Country	Name	City	State
Poland	Vitamed Galaj I Cichomski sp.j.	Bydgoszcz
Poland	Centrum Medyczne Lukamed.	Chojnice
Poland	Silmedic sp. z o.o.	Katowice
Poland	Santa Sp. z o.o. Santa Familia PTG Lodz	Lódz
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o	Malbork
Poland	Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Zegota	Ostróda
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Quality Research Inc	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
HALEON

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at 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.	Baseline and Week 1
Primary	Change from Baseline in the Average Minutes of MVPA at 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.	Baseline and Week 2
Primary	Change from Baseline in the Average Minutes of MVPA at 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.	Baseline and Week 3
Secondary	Change from Baseline in Daily Average Number of Steps Taken at 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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in Daily Average Number of Stairs Climbed/Descended at 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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in Ratio of Sedentary/Non-sedentary Time at 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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at 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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in Indices of Morning Stiffness at 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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on 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.	Baseline, Days 7, 14 and 21
Secondary	MVPA on Each Day of the Study	The average minutes of MVPA will be measured through a connected activity tracker (Actigraph device) worn by the participants.	Baseline up to Day 21
Secondary	WOMAC Physical Function Subscale Score on 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.	Days 7, 14 and 21
Secondary	Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS)	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.	Baseline up to Day 21
Secondary	Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain	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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness	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.	Baseline, Days 7, 14 and 21
Secondary	Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on 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.	Baseline, Days 7, 14 and 21
Secondary	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	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.	Baseline, Days 7, 14 and 21