A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain

Last updated: November 19, 2024
Sponsor: HALEON
Overall Status: Completed

Phase

4

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

NCT06379893
300128
2024-510839-22-00
  • Ages 40-85
  • All Genders

Study 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

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

Total Participants: 196
Treatment Group(s): 3
Primary Treatment: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only)
Phase: 4
Study Start date:
April 25, 2024
Estimated Completion Date:
October 29, 2024

Study 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.

Connect with a study center

  • Vitamed Gałaj I Cichomski sp.j.

    Bydgoszcz, 85-079
    Poland

    Site Not Available

  • Centrum Medyczne Lukamed.

    Chojnice, 89-600
    Poland

    Site Not Available

  • Silmedic sp. z o.o.

    Katowice, 40-282
    Poland

    Site Not Available

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o

    Malbork, 82-200
    Poland

    Site Not Available

  • Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Żęgota

    Ostróda, 14-100
    Poland

    Site Not Available

  • Santa Sp. z o.o. Santa Familia PTG Lodz

    Łódź, 90-302
    Poland

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Quality Research Inc

    San Antonio, Texas 78209
    United States

    Site Not Available

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