PainPhase 4NCT06379893
A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain
A Phase 4 study testing Voltaren Gel in people with Pain, run by HALEON at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- Voltaren Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Apr 2024to 29 Oct 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Poland6 sites
Vitamed Gałaj I Cichomski sp.j.
Bydgoszcz, 85-079
Centrum Medyczne Lukamed.
Chojnice, 89-600
Silmedic sp. z o.o.
Katowice, 40-282
Santa Sp. z o.o. Santa Familia PTG Lodz
Lodz, 90-302
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
Malbork, 82-200
Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Żęgota
Ostróda, 14-100
United States2 sites
Tandem Clinical Research
Marrero, Louisiana, 70072
Quality Research Inc
San Antonio, Texas, 78209
About this study
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
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.
Read the 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
- Being tested
- Voltaren Gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voltaren GelDrug
Diclofenac sodium gel in 3 different concentrations as- Diclofenac sodium 1%, 1.16% and 2.32% whichever was available in the given region.
| Study group | Role | What they receive |
|---|---|---|
| Voltaren Gel | Experimental | 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. Receives: Drug: Voltaren Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1
The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A mixed model with repeated measures (MMRM) was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 1. Baseline value was calculated as the sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement. Modified Intent-To-Treat (mITT) population included all participants who met the inclusion/exclusion criteria, who used study product at least once and had data from at least one post Baseline quality of life (QoL) questionnaire to support at least one of the secondary endpoint assessments.
Measured: Baseline and Week 1
Change From Baseline in the Average Minutes of MVPA at Week 2
The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 2. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
Measured: Baseline and Week 2
Change From Baseline in the Average Minutes of MVPA at Week 3
The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 3. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
Measured: Baseline and Week 3
Secondary outcomes (15)
Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3
Daily average number of steps taken were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on functional mobility. MMRM was used to analyse the change from Baseline in daily average number of steps taken. Change from Baseline was calculated by subtracting the average number of steps taken at Baseline from the average number of steps taken at each indicated post-Baseline timepoint. Baseline value was calculated as the sum of steps taken over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3
Sedentary/non-sedentary time was measured using a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on functional mobility. Ratio of sedentary/non-sedentary time was calculated as = Total number of minutes defined as sedentary behaviour divided by Total number of non-sedentary behaviour minutes where number of non-sedentary behaviour minutes in the day was derived as the sum of light activity and MVPA. Change from Baseline was calculated by subtracting the Baseline ratio of sedentary/non-sedentary time from the ratio at each indicated post-Baseline timepoint. Baseline was defined as the number of non-missing days between Day -6 and Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3
Gait was assessed through speed and step irregularity measured via cadence using a connected activity tracker (Actigraph device) worn by the participants. Change from Baseline was calculated as by subtracting the average cadence at Baseline from the cadence at each indicated post-Baseline timepoint. Baseline was defined as the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3
Gait was assessed through speed and step irregularity measured via gait speed using a connected activity tracker (Actigraph device) worn by the participants. Change from Baseline was calculated by subtracting the average gait speed at Baseline from the Average gait speed at each indicated post-Baseline timepoint. Baseline was defined as the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3
Indices of morning stiffness were assessed through levels of mobility 30 minutes post-wake. Functional mobility was measured through a connected activity tracker (Actigraph device) worn by the participants. Daily morning stiffness 30 minutes post-wake was defined as the total vector magnitude counts from Actigraph device 30 minutes post-wake. Change from Baseline was calculated as = (Average morning stiffness 30 minutes post-wake at each indicated post-Baseline timepoint minus Average Baseline morning stiffness 30 minutes post-wake). Baseline was defined as the number of non-missing days between Day -6 and Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3
Indices of morning stiffness were assessed through levels of mobility 60 minutes post-wake. Functional mobility was measured through a connected activity tracker (Actigraph device) worn by the participants. Daily morning stiffness 60 minutes post-wake was defined as the total vector magnitude counts from Actigraph device 60 minutes post-wake. Change from Baseline was calculated as = (Average morning stiffness 60 minutes post-wake at each indicated post-Baseline timepoint minus Average Baseline morning stiffness 30 minutes post-wake). Baseline was defined as the number of non-missing days between Day -6 and Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3
Participants completed the WOMAC questionnaire daily using eDiary. The WOMAC questionnaire consisted of 24 questions categorised in 3 subscales - Pain, Stiffness, Physical function. The physical function subscale consisted of 17 questions related to level of difficulty in performing functions, on average, during the last 48 hours scored on a 5-point Likert scale with scores ranging from 0 to 4, where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. Total WOMAC physical function subscale score was normalized on a 0 to 100 scale calculated as = (sum of raw score items)*1.47. Higher scores indicated more difficulty in performing physical functions. Change from Baseline was calculated by subtracting the normalized WOMAC subscale score at Baseline from the normalized WOMAC subscale score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
MVPA on Each Day of the Study
The average minutes of MVPA on each day were measured through a connected activity tracker (Actigraph device) worn by the participants to assess the functional mobility. Baseline was calculated as the average of MVPA values collected during the Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0.
Measured: Baseline up to Day 21
WOMAC Physical Function Subscale Score at Weeks 1, 2 and 3
Physical function subscale score of the WOMAC questionnaire was used to study participant's perceived ability to exercise more regularly. It consisted of 17 questions related to the level of difficulty in performing functions, on average, during the last 48 hours scored on a 5-point Likert scale with scores ranging from 0 to 4, daily using eDiary where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. Total WOMAC physical function subscale score was normalized on a 0 to 100 scale calculated as = (sum of raw score items)*1.47. Higher scores indicated more difficulty in performing physical functions.
Measured: Week 1, Week 2 and Week 3
Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3
Participants rated 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 indicated greater pain intensity. Change from Baseline was calculated by subtracting the Baseline NRS score from the NRS score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3
Participants completed the WOMAC questionnaire daily. The WOMAC questionnaire consisted of 24 questions each scored on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The WOMAC questionnaire was categorized in 3 subscales - Pain (5 questions, score ranges 0-20), Stiffness (2 questions, score ranges 0-8), Physical function (17 questions, score ranges 0-68). Each subscale score was normalized on a 0 to 100 scale calculated as: Pain subscale score= (sum of raw score items in dimension)*5; Stiffness subscale score= (sum of raw score items in dimension)*12.5; Physical function subscale score= (sum of raw score items in dimension)*1.47. WOMAC Total score = sum of the 3 normalized WOMAC subscale scores. Thus, WOMAC total score ranges from 0 to 300 with 0 being the best and 300 being the worst. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated post-Baseline timepoint. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3
The pain subscale of the WOMAC questionnaire consisted 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 scored the questions on a 5-point Likert scale ranging from 0 to 4 daily using eDiary where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total pain subscale score was normalized on a 0 to 100 scale calculated as = (sum of raw score items in dimension)*5. Higher scores indicated more pain. Change from Baseline was calculated by subtracting the Baseline normalized WOMAC pain subscale score from the normalized score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3
The stiffness subscale of the WOMAC questionnaire consisted 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 scored the questions on a 5-point Likert scale with scores ranging from 0 to 4 daily using eDiary, where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total stiffness subscale score for was normalized on a 0 to 100 scale calculated as = (sum of raw score items in dimension)*12.5. Higher scores indicated more stiffness. Change from Baseline was calculated by subtracting the Baseline normalized WOMAC stiffness subscale score from the normalized score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21
KSS measured the subjective level of sleepiness/alertness during the day. Participants rated how sleepy or alert they were feeling using KSS with scores ranging 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 indicated greater sleepiness. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.
Measured: Baseline, Day 7, Day 14, and Day 21
Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21
Health-related QoL of participants was assessed using the EQ-5D-5L questionnaire. It consisted 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 were asked to indicate their health by ticking the box next to the most appropriate response level for each dimension. The response levels were used to derive a health index score based on the Crosswalk Value Set for the United States ranging from less than 0 (worst imaginable health) to 1 (best imaginable health) where higher scores indicated better health. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. Baseline was defined as Day 0. A positive change from Baseline indicated improvement.
Measured: Baseline, Days 7, 14 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start25 Apr 2024
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379893
- Sponsor's protocol ID
- 300128
- Other IDs
- 2024-510839-22-00
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2024
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06379893
- Acronym / sponsor ID
- 300128
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Posted 20 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voltaren Gel | Experimental | Drug: Voltaren GelParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voltaren GelDiclofenac sodium gel in 3 different concentrations as- Diclofenac sodium 1%, 1.16% and 2.32% whichever was available in the given region. | Drug | Voltaren Gel |
Primary outcome
Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1
Time frame: Baseline and Week 1
The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A mixed model with repeated measures (MMRM) was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 1. Baseline value was calculated as the sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement. Modified Intent-To-Treat (mITT) population included all participants who met the inclusion/exclusion criteria, who used study product at least once and had data from at least one post Baseline quality of life (QoL) questionnaire to support at least one of the secondary endpoint assessments.
Change From Baseline in the Average Minutes of MVPA at Week 2
Time frame: Baseline and Week 2
The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 2. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
Change From Baseline in the Average Minutes of MVPA at Week 3
Time frame: Baseline and Week 3
The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 3. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.
15 secondary outcomes
Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
MVPA on Each Day of the Study
Time frame: Baseline up to Day 21
WOMAC Physical Function Subscale Score at Weeks 1, 2 and 3
Time frame: Week 1, Week 2 and Week 3
Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3
Time frame: Baseline, Week 1, Week 2 and Week 3
Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21
Time frame: Baseline, Day 7, Day 14, and Day 21
Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21
Time frame: Baseline, Days 7, 14 and 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Voltaren Gel in people with Pain, run by HALEON at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 (time frame: Baseline and Week 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.