Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: Prospective, Placebo Controlled, Randomized, Double-Blinded Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Lipo-Sphere
- Enrollment
- 92
- Locations
- 3
- Primary Endpoint
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) PAIN
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
- •History of significant knee trauma or previous surgery of the intended study knee within the last 3 months preceding the screening
- •Pain in both knees with a VAS score of ≥5
- •Intra-articular injection to the intended study knee within 3 months before Screening
- •Significant instability of the index knee
- •Malalignment more than 10 degrees varus OR 10 degrees valgus according to standing X-ray
- •Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study
- •History of Psoriatic Arthritis, Rheumatoid Arthritis, or any other inflammatory condition associated with arthritis
- •Wound in the area of the intended study knee
- •Any known tumor of the index knee
Outcomes
Primary Outcomes
The Knee Injury and Osteoarthritis Outcome Score (KOOS) PAIN
Time Frame: Baseline up to 12 weeks
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)
Secondary Outcomes
- PGA(Baseline to 6,12 and26 weeks)
- Numerical Rating Scale (NRS) Pain Score(Assessed at1, 6, 12, and 26 weeks from baseline.)
- Knee Injury and Osteoarthritis Outcome Score Responder Rates(Baseline to 12 weeks)
- Subscores-Specific KOOS Improvements(Baseline to 6,12 and26 weeks)
- Safety(baseline to 6 month)