Phase 4
N=196
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
Bottom Line
View on ClinicalTrials.gov: NCT06379893 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 — 249.2; 14.2 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Voltaren Gel (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 |
249.2; 14.2 | <0.001 sig |
| PRIMARY Change From Baseline in the Average Minutes of MVPA at Week 2 |
249.2; 10.7 | 0.001 sig |
| PRIMARY Change From Baseline in the Average Minutes of MVPA at Week 3 |
249.2; -0.8 | 0.653 |
| SECONDARY Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3 |
13826.5; 602.3; 323.1; -57.1 | 0.001 sig |
| SECONDARY Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3 |
1.984; -0.028; 0.003; 0.089 | 0.473 |
| SECONDARY Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3 |
109.207; -0.149; -1.126; -1.751 | 0.261 |
| SECONDARY Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3 |
1.010; -0.007; -0.016; -0.016 | — |
| SECONDARY Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3 |
75593.364; 1969.758; 2332.422; -1893.342 | 0.221 |
| SECONDARY Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3 |
149034.401; 2891.276; 2438.403; -6734.944 | 0.289 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3 |
48.702; -8.677; -11.926; -15.644 | <0.001 sig |
| SECONDARY MVPA on Each Day of the Study |
249.2; 274.1; 268.4; 259.3; 270.8; 255.8 | — |
| SECONDARY WOMAC Physical Function Subscale Score at Weeks 1, 2 and 3 |
40.375; 37.072; 32.781 | — |
| SECONDARY Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3 |
5.7; -1.5; -1.9; -2.6 | <0.001 sig |
| SECONDARY Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3 |
147.040; -27.359; -36.062; -47.852 | <0.001 sig |
| SECONDARY Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3 |
48.196; -9.458; -12.422; -16.383 | <0.001 sig |
| SECONDARY Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3 |
50.142; -9.242; -11.719; -15.680 | <0.001 sig |
| SECONDARY Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21 |
3.9; -0.2; -0.2; -0.4 | 0.237 |
| SECONDARY Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21 |
0.67; 0.04; 0.05; 0.07 | <0.001 sig |
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.
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 w
Data sourced from ClinicalTrials.gov (NCT06379893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.