Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title: Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: Prospective, Placebo Controlled, Randomized, Double-Blinded Study

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to evaluate the Efficacy and Safety of AqueousJoint Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis of AqueousJoint.

The main questions it aims to answer are:

• To demonstrate superior efficacy of AqueousJoint administered via intra-articular injection versus placebo during the study period.

• To evaluate the efficacy of two different concentrations of AqueousJoint, administered via single IA injection as compared to control group (placebo) One IA injection of AqueousJoint or Placebo will be injected to participants' knee. Follow up will take place up to six months.

Clinical Trial Description

This study aims to assess the efficacy 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.

Primary Efficacy Objective The primary objective is to demonstrate the superior efficacy of AqueousJoint administered via intra-articular injection versus placebo during the study period in terms of pain reduction. Pain and functional outcomes will be assessed using VAS and KOOS at each FU visit (up to and including 12 weeks) and compared to the baseline levels.

Secondary Efficacy Objective The secondary objective is to assess changes from baseline to 26 weeks in KOOS Pain, symptoms, QOL, ADL and sport subscores. Change from Baseline in Patient's Global Assessment (PGA) and Evaluators' Global Assessment (EGA) of Osteoarthritis at Week 26 will be evaluated.

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). ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT05771948
• Study type: Interventional
• Source: Lipo-Sphere
• Contact: Alisa Yelisov, SC
• Phone: 972-54-5803409
• Email: alisay@assuta.co.il
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Completion date: December 2024