Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis (NCT05771948) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis
Israel125 participantsStarted 2023-03-16
Plain-language 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.
Who can participate
Age range30 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subject has signed and dated the informed consent form
✓. Age ≥30 and ≤ 85 years old
✓. Pain in the intended study knee with an average VAS score (active) of ≥3 over the last week before screening.
✓. Degenerative changes in the intended study knee that can be categorized as grade I -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographsof the knee
✓. Body Mass Index (BMI) between 18.5 and 38
✓. A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of AqueousJoint.
✓. If female, the subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential using at least 2 methods of birth control that are effective from at least 30 days before Visit 1 through visit 26w (26 weeks post injection).
✓. Are willing or able to comply with procedures required in this protocol.