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Nonsteroidal Anti-Inflammatory Drug

Diclofenac Gel for Osteoarthritis

N/A

Waitlist Available

Led By Michelle Dossett, MD, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

50 years of age or older

Knee pain at least 15 days/month

Must not have

Current use of topical or oral NSAIDs more than 3 days per week

Medical contraindication to taking NSAIDs such as: history of coronary artery bypass graft, myocardial infarction, systolic heart failure with ejection fraction <45%, chronic kidney disease stage ≥4, severe gastrointestinal bleed or stomach ulcer within the past 6 months, current pregnancy, cirrhosis, currently taking blood thinners, or allergy to NSAIDs or aspirin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to understand how patient and clinic visit details influence the outcomes of using diclofenac gel for knee osteoarthritis pain. They want to know if certain patient characteristics, physiology during

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Topical Diclofenac may cause skin irritation at the application site, stomach problems if absorbed into the bloodstream in significant amounts, liver issues, or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use NSAID medications more than three times a week.

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

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I am not currently undergoing cancer treatment and my life expectancy is more than 6 months.

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I am able to understand and consent to medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee Function

Knee Pain

Secondary study objectives

Change in patient RMSSD (root mean square of successive differences)

Change in patient skin conductance response

Global Impressions

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DiclofenacExperimental Treatment1 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.

0 / 6Eligibility criteria met