Can voltaren gel get you moving again? new study says maybe.
NCT ID NCT06379893
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study looked at how Voltaren Gel (a topical pain reliever) affects mobility and quality of life in 196 adults with knee osteoarthritis pain. Participants used the gel as directed for up to 3 weeks while wearing an activity tracker. The goal was to see if the gel helps people become more active and feel better in their daily lives.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Voltaren Gel (diclofenac sodium gel)
- What this could lead to
- If it works, this could confirm that Voltaren Gel helps people with knee osteoarthritis move more easily and feel better in daily life.
- What could go wrong
- This is a completed Phase 4 real-world study, so results are already in. However, it was small (196 people) and not blinded, so findings may not be definitive or apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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196 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
Malbork, 82-200, Poland
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Centrum Medyczne Lukamed.
Chojnice, 89-600, Poland
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Quality Research Inc
San Antonio, Texas, 78209, United States
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Santa Sp. z o.o. Santa Familia PTG Lodz
Lodz, 90-302, Poland
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Silmedic sp. z o.o.
Katowice, 40-282, Poland
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Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Żęgota
Ostróda, 14-100, Poland
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Tandem Clinical Research
Marrero, Louisiana, 70072, United States
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Vitamed Gałaj I Cichomski sp.j.
Bydgoszcz, 85-079, Poland
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