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.
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:
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.
The average walking pain intensity during previous 24 hours in the index knee should be ≥40 mm on VAS (100 mm) at screening and prior to planned start of treatment.
In case the patient uses helper (cane) during the walking, he/she should have been using it routinely during at least previous 6 months. The same helper should be used during the study.
Patients who can use cream for 28-32 consecutive days (through the trial).
Women of childbearing potential must agree to use an acceptable barrier method of contraception during study participation.
Exclusion Criteria:
Participants will receive Cetilar® cream containing cetylated fatty acids, applied topically to the affected knee twice daily (every 12±1 hours) for 30 days.
Participants will receive matching placebo cream applied topically to the affected knee twice daily (every 12±1 hours) for 30 days.
Tbilisi, Georgia
Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee
A Clinical Trial to Investigate the Efficacy and Safety of a Plant-derived Cetylated Fatty Acids (CFA) on Knee Pain and Stiffness in Healthy Adults With Persistent Knee Pain
Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis.
Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain
CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle