The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren \& Lawrence grade 2 knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
Invossa K Inj.
Placebo control
Korea University Anam Hospital
Ansan, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
IKDC (International knee documentation committee) Subjective Knee Evaluation
Changes in IKDC Subjective Knee Evaluation (score)
Time frame: Week 0 and 52
100 mm VAS (Visual analogue scale)
Changes in 100 mm VAS
Time frame: Week 0 and 52
WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score
Changes in WOMAC (score)
Time frame: Week 0, 26, 39 and 52
IKDC Subjective Knee Evaluation
Changes in IKDC Subjective Knee Evaluation (score)
Time frame: Week 0, 26 and 39
100 mm VAS
Changes in 100 mm VAS
Time frame: Week 0, 26 and 39
OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate
OMERACT-OARSI response rate after administration (%)
Time frame: Week 26, 39 and 52
MRI scan
Changes in MRI scan
Time frame: Week 0, and 52
Joint Space Width
Changes in Joint Space Width (mm)
Time frame: Week 0, and 52
Biomarker (CTX-I) in blood
Levels of CTX-I in blood (ng/ml)
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Kyungpook National University School of Medicine
Daegu, South Korea
Chungnam National University School of Medicine
Daejeon, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Inha University Hospital
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
College of Medicine, Hanyang University
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
...and 7 more locations
Time frame: Week 0, 26, and 52
Biomarker (CTX-II) in urine
Levels of CTX-II in urine (ng/ml)
Time frame: Week 0, 26, and 52
Rescue Medication (Dosage)
Dosage of Rescue Medication (mg)
Time frame: Week 0, 4, 12, 26, 39, and 52
Rescue Medication (Frequency)
Frequency of Rescue Medication (number)
Time frame: Week 0, 4, 12, 26, 39, and 52
Drop-out rate
Drop-out rate (%)
Time frame: Week 0, 4, 12, 26, 39, and 52
Reason of drop-out
Reason of drop-out is recorded in CRF (Case Report Form), when the patient is dropped-out according to drop-out criteria (e.g. Withdraw a consent, Patients who can not continuously participate in study due to adverse events, Impossible to follow-up of the patient. etc.).
Time frame: Week 0, 4, 12, 26, 39, and 52