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Nonsteroidal Anti-inflammatory Drug

Diclofenac Cream 8% for Knee Injuries

Phase 3
Waitlist Available
Research Sponsored by FPR Specialty Pharmacy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Acute and chronic knee pain, along with postoperative knee pain lasting at least two months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily measurement for 6 weeks
Awards & highlights

Summary

Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. For example, they are often used for knee pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects. Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied commercially available products are diclofenac 1% compounds. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect. The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity. One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.

Eligible Conditions
  • Knee Injuries
  • Chronic Knee Pain

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily measurement for 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily measurement for 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Descrete Response Scale Pain Scores

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diclofenac Cream 8%Experimental Treatment1 Intervention
Diclofenac Cream 8% applied 3-4 times daily for 6 weeks.
Group II: ControlActive Control1 Intervention
Diclofenac Gel 1% applied 3-4 times daily fr 6 weeks

Find a Location

Who is running the clinical trial?

FPR Specialty PharmacyLead Sponsor
~9 spots leftby Sep 2025