The goal of this clinical trial is to evaluate the Efficacy and Safety of CCoat Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis. The main questions it aims to answer are: * To demonstrate superior efficacy of CCoat administered via intra-articular injection versus placebo during the study period. * To evaluate the efficacy of two different concentrations of CCoat, administered via single IA injection as compared to control group (placebo) One IA injection of CCoat or Placebo will be injected to participants' knee. Follow up will take place up to six months. * To evaluate the safety of the repeated CCoat injection administered at six months.
This study aims to assess the effectiveness and safety of intra-articular injection of Aqueous Joint at two different concentrations administered via a single injection in osteoarthritic patients up to 26 weeks of follow-up in a double-blind, randomized clinical study. Additionally, the safety of the repeated injection will be examined. Primary Effectiveness Objective The primary objective is to demonstrate the superior effectiveness of CCoat administered via single intra-articular injection versus placebo during the study period in terms of functional outcomes as assessed in terms of Pain KOOS subscore at each FU visit (up to and including 12 weeks) and compared to the baseline levels. Secondary Effectiveness Objective The secondary objective is to assess changes from baseline to 26 weeks in NRS, KOOS symptoms, QOL, ADL and sport subscores. Change from Baseline in Patient's Global Assessment (PGA)) of Osteoarthritis at Week 26 were evaluated. Patients responder rates will be evaluated at 12 and 26 weeks. Safety Objectives Safety will be evaluated by the occurrence of Adverse Events during the study. Adverse Events will be reported in terms of incidence, severity, and frequency of all Adverse Events (AE). Clinical Hypotheses The underlying clinical hypothesis of this study is that the CCoat is superior to the control group in terms of KOOS score (Pain, Symptoms, QOL, ADL \& Sports) at 3 months compared to baseline, even more in a high concentration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from joint pain developed by Liposphere LTD. CCoat is a liposomal boundary lubricant which coats the cartilage surface and protects it from further damage and degradation.
Assuta
Ashdod, Israel
RECRUITINGSheba Medical Center
Ramat Gan, Israel
RECRUITINGKaplan Medical Center
Rehovot, Israel
RECRUITINGThe Knee Injury and Osteoarthritis Outcome Score (KOOS) PAIN
Change from baseline in patients KOOS pain over the course of the 12-week initial treatment period as measured by using the Knee injury and Osteoarthritis Outcome Score (KOOS) in following subscore: Pain- \[Time Frame: Day 0, up to week 12\] The responses for the KOOS Pain subscale are then summed and transformed into a score ranging from 0 to 100, where: 0 represents extreme problems (maximum pain) 100 represents no problems (no pain)
Time frame: Baseline up to 12 weeks
Numerical Rating Scale (NRS) Pain Score
Change in Numerical Rating Scale (NRS) Pain. The NRS asks patients to rate their pain on a scale from 0 to 10, where: 0 represents "No pain" 10 represents "Worst possible pain"
Time frame: Assessed at1, 6, 12, and 26 weeks from baseline.
PGA
Change in Patient's Global Assessment (PGA). PGA assessment includes 5 options to answer - between 1 to 5 - which 1 means 'very good' , and 5 means 'very poor'.
Time frame: Baseline to 6,12 and26 weeks
Knee Injury and Osteoarthritis Outcome Score Responder Rates
A responder is defined as an improvement of at least 8 points or ≥ 20% from baseline in the each of the KOOS subscores (Pain; Activities of Daily Living (ADL);Quality of Life (QOL);Symptoms; Sports; Overall KOOS score) The MCID is the smallest change in a score that patients perceive as beneficial. For the KOOS, an improvement of around 8 points in a subscale score is often considered a clinically meaningful change. A patient might be considered a responder if they achieve at least the MCID in one or more of the KOOS subscales (Pain, ADL, Sports, Symptoms, QOL).
Time frame: Baseline to 12 weeks
Subscores-Specific KOOS Improvements
Measured Change in the following KOOS subscores ( pain, ADL, sports, symptoms, QOL) Each of the five KOOS subscales is scored separately on a scale from 0 to 100, where 0 represents extreme problems and 100 represents no problems. Calculate the Change: Subtract the baseline score from the follow-up score for each subscale. Change in KOOS Subscale = Follow-Up Score - Baseline Score A positive change indicates improvement (e.g., less pain, better ADL, better sports function). A negative change indicates worsening (e.g., more pain, worse ADL).
Time frame: Baseline to 6,12 and26 weeks
Safety
Adverse events, including serious adverse events
Time frame: baseline to 6 month
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