NCT05771948

Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: Prospective, Placebo Controlled, Randomized, Double-Blinded Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Lipo-Sphere · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	CCoat	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.

Timeline

• Start date: 2023-03-16
• Primary completion: 2025-03-01
• Completion: 2025-06-01
• First posted: 2023-03-16
• Last updated: 2026-02-27

Locations

3 sites across 1 country: Israel