Diclofenac Gel for Osteoarthritis

Overseen By Maya Porter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Blood thinners, NSAIDs

Disqualifiers: Inflammatory arthritis, Knee replacement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to understand the patient and clinic visit characteristics that affect health outcomes for individuals with knee osteoarthritis (OA) pain using topical diclofenac gel. The main questions it aims to answer are: * What baseline patient characteristics predict response to topical diclofenac? * Does patient physiology during the study visit predict response to topical diclofenac? * Do study visit characteristics predict response to topical diclofenac? Participants will: * attend 2 study visits to complete study questionnaires and have blood drawn * apply topical diclofenac to their knee for 8 weeks * complete biweekly questions about knee pain and diclofenac use between study visits

Who Is on the Research Team?

Michelle Dossett, MD, PhD, MPH

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis who are willing to apply diclofenac gel on their knee and can attend two study visits. Participants will also need to answer biweekly questions about their knee pain and treatment usage.

Inclusion Criteria

English-speaking

I experience knee pain for at least 15 days each month.

I am 50 years old or older.

Exclusion Criteria

I use NSAID medications more than three times a week.

Inability to receive text messages or email

I cannot take NSAIDs due to a serious health condition or allergy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Study Visit

Participants attend the first study visit to complete baseline questionnaires, have blood drawn, and receive diclofenac gel

1 day

1 visit (in-person)

Treatment

Participants apply topical diclofenac to their knee for 8 weeks and complete biweekly questions about knee pain and diclofenac use

8 weeks

Biweekly virtual check-ins

Follow-up

Participants attend a follow-up visit to complete final questionnaires and assess outcomes

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Topical Diclofenac gel

Trial Overview The study aims to determine how patient characteristics, physiological responses during clinic visits, and the nature of these visits influence the effectiveness of topical diclofenac gel in managing knee OA pain.

How Is the Trial Designed?

Group I: Diclofenac Experimental Treatment 1 Intervention

All study participants receiving topical diclofenac gel 1%. Participants will be instructed to apply 4 grams of the gel to the index knee at least once per day, and up to 4 times per day, for 8 weeks.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+