Effect of a Topical Cetylated Fatty Acid Cream on Pain Relief in Patients With Knee Osteoarthritis (NCT07745387) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Topical Cetylated Fatty Acid Cream on Pain Relief in Patients With Knee Osteoarthritis
Georgia156 participantsStarted 2024-06-24
Plain-language summary
This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream in adults with osteoarthritis-related knee pain. The study will assess the effects of treatment on knee pain, physical function, use of rescue medication, quality of life, and safety outcomes.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated written informed consent.
. Male or female participants aged 40 to 75 years.
. Diagnosis of idiopathic knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
. Compliance of the disease course with the following criteria:
. symptoms for at least 6 months prior to screening
. index knee pain for at least 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendinitis, etc.);
. walking arthritis pain required the periodic use of acetaminophen or NSAIDs (topical or oral products) on demand.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a topical cetylated fatty acid cream for knee osteoarthritis pain — is this type of cream something you'd consider appropriate for my situation, and is it available outside of a research setting?
2The trial measured pain during walking using a VAS score — given my current level of walking pain, how significant would a change in that score need to be to actually make a difference in my day-to-day life?
3Since this trial is listed as Phase NA and has already completed, does that mean the safety and effectiveness results are available yet, and would they be strong enough evidence to guide my treatment?
4Before trying a topical cream like this, should I first work through more established treatments for knee osteoarthritis, like physical therapy or anti-inflammatory medications, or could this be used alongside them?
5Are there any known risks or skin reactions associated with cetylated fatty acid creams that I should be aware of before discussing this as an option with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Walking Arthritis Pain Intensity Score (VAS)
. Presence of X-ray (taken no more than 3 months before baseline) showing evidence of osteoarthritis with Kellgren-Lawrence grade 2-3 in the index knee.
Exclusion criteria
. Intolerance or allergic reactions to any component of the study therapy. Severe hypersensitivity reactions to any drugs in past medical history.
. Usage of NSAIDs within 3 days or steroids within 7 days prior to planned start of treatment. In case when drug elimination exceeds defined period, it should be cancelled for the period of at least 5 half-lives.
. Usage of intra-articular hyaluronic acid injections for period less than 3 months prior to the planned start of treatment.
. Usage of DMOADs (disease-modifying osteoarthritis drugs) for period less than 3 months prior to the planned start of treatment.
. Open skin lesions or dermatological conditions at the site of cream application.
. Data on another etiology of the index knee joint lesion: gout, chondrocalcinosis, septic arthritis, infectious arthritis, Paget disease, aseptic osteonecrosis, seronegative spondyloarthropathies (psoriatic arthritis, ankylosing spondyloarthritis), metabolic (ochronosis, hemochromatosis) or autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus).
. Surgery or major trauma of the index knee within the previous 12 months.
. Presence of pain that could interfere with the assessment of knee pain (e.g. pain in any other part of the target lower extremity, pain radiating to the knee).