Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT06379893
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT06379893
Study Brief:
Protocol Section:
NCT06379893