Phase
Condition
Pain
Osteoarthritis
Treatment
Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only)
Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only)
Voltaren Gel 1% (diclofenac sodium) (US only)
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant provision of a signed and dated informed consent document indicatingthat the participant has been informed of all pertinent aspects of the study beforeany 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-labelVoltaren 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 viaradiological 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 visualanalogue scale at the time of Informed Consent Form (ICF) signature.
A participant willing to use Voltaren Gel for up to 3 weeks.
Exclusion
Exclusion Criteria:
A participant who is an employee of the investigational site, either directlyinvolved in the conduct of the study or a member of their immediate family; or anemployee of the investigational site otherwise supervised by the investigator; or aHaleon employee directly involved in the conduct of the study or a member of theirimmediate family.
A participant who has participated in other studies (including non-medicinalstudies) involving investigational product(s) within 1 month prior to study entryand/or during study participation.
A participant with, in the opinion of the investigator or medically qualifieddesignee, an acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the investigator or medically qualifieddesignee, 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 thatresulted in pain and/or swelling.
A participant that has been administered local steroids or other Non-steroidalanti-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 applicationof 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: Gastrointestinaldiseases, asthma, hypertension, myocardial infarction, thrombotic events, stroke,congestive heart failure, impaired renal function, or liver disease as judged byinvestigator 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 tricyclicantidepressants or anticonvulsants.
A participant with an active infection.
A participant who is pregnant, lactating, or plan to be pregnant or lactating duringthe 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 30days of study.
A participant with known or suspected intolerance or hypersensitivity to the studymaterials (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 theintegrity of study data or place the participant at risk by participating in thestudy.
A participant who, in the opinion of the investigator or medically qualifieddesignee, should not participate in the study.
Study Design
Study Description
Connect with a study center
Vitamed Gałaj I Cichomski sp.j.
Bydgoszcz, 85-079
PolandSite Not Available
Centrum Medyczne Lukamed.
Chojnice, 89-600
PolandSite Not Available
Silmedic sp. z o.o.
Katowice, 40-282
PolandSite Not Available
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
Malbork, 82-200
PolandSite Not Available
Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Żęgota
Ostróda, 14-100
PolandSite Not Available
Santa Sp. z o.o. Santa Familia PTG Lodz
Łódź, 90-302
PolandSite Not Available
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
Quality Research Inc
San Antonio, Texas 78209
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.