An exploratory double-blind randomized placebo-controlled trial to evaluate the effect of ARTENSIUM® cream in the relief of pain in patients with knee osteoarthritis

Condition studied

Knee osteoarthritis is a chronic degenerative joint disease characterised by progressive deterioration of the articular cartilage and structural changes affecting the entire joint. Patients commonly experience knee pain, stiffness, reduced physical function and impaired quality of life. This study focuses on adults with symptomatic knee osteoarthritis experiencing knee pain requiring therapeutic management.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in the KOOS Pain subscale score, assessed longitudinally between Day 0, Day 7, and Day 14, with the primary estimate of treatment effect at Day 14. If the patient experiences pain in both knees, only the most painful knee will be assessed.

Endpoint detail

Change in pain VAS score between Day 0, Day 7 and Day 14., Change in the KOOS Symptoms subscale between Day 0, Day 7 and Day 14., Change in the KOOS ADL Function subscale between Day 0, Day 7 and Day 14., Change in the KOOS Quality of Life subscale between Day 0, Day 7 and Day 14., PGIC (Patient Global Impression of Change) score at Day 0, Day 7 and Day 14., Change in pain VAS score assessed at three time points: before application, 2 hours post-application, and 4 hours post-application at the first application, and subsequently at Day 7 and Day 14 (after the morning application)., • Cumulative quantity of rescue medication used between Day 0 and Day 14 • Maximum daily quantity used between Day 0 and Day 14 • Number of daily intakes between Day 0 and Day 14., Proportion of patients requiring analgesic treatment during follow-up • Number of days with analgesic use during follow-up • Type of analgesic treatments used (paracetamol, NSAIDs, opioids, others) • Cumulative quantity of analgesics used during follow-up., Proportion of administered doses as reported in the patient diary between Day 0 and Day 14., Overall satisfaction • Ease of spreading • Texture (stickiness, residual film) • Ease of use • Odor • Visual appearance • Intention to reuse the product.