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

NCT ID: NCT06379893

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2024-10-29

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Voltaren Gel

Participants will use Voltaren Gel 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.

Group Type: EXPERIMENTAL

Voltaren Gel

Intervention Type: DRUG

Diclofenac sodium gel in 3 different concentrations as- Diclofenac sodium 1%, 1.16% and 2.32% whichever was available in the given region.

Interventions

Voltaren Gel

Diclofenac sodium gel in 3 different concentrations as- Diclofenac sodium 1%, 1.16% and 2.32% whichever was available in the given region.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HALEON

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tandem Clinical Research

Marrero, Louisiana, United States

Quality Research Inc

San Antonio, Texas, United States

Vitamed Gałaj 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

Lodz, , Poland

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o

Malbork, , Poland

Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Żęgota

Ostróda, , Poland

Countries

United States; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2024-510839-22-00

Identifier Type: CTIS

Identifier Source: secondary_id

300128

Identifier Type: -

Identifier Source: org_study_id