knee osteoarthritis
Conditions
Interventions
LBSA0103:ntra-articular injection of LBSA0103 (60mg/3mL/vial) only once at the first week and then sham injection once weekly for consecutive 2 weeks
Synvisc:ntra-articular injection of Synvisc (16mg/2mL/vial) once weekly for consecutive 3 weeks
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. A patient diagnosed with one- or both-knee osteoarthritis (mild to moderate) based on Guidelines for Diagnosis and Treatment of Osteoarthritis (Ver. 2018). If meeting more than one diagnosis criteria (any two of criteria 2, 3, 4 and 5), it can be diagnosed as osteoarthritis of knee joint: 1). Repeated knee pain in recent one month 2). X-ray (standing or weightbearing) suggested narrowed joint space, subchondral osteosclerosis and (or) cystic degeneration or joint edge osteophyte formation 3). Age = 50 4). Morning stiffness = 30 min 5). Bony crepitus on active motion (felt) 2. Adult male or female patient of over 40 years of age diagnosed with knee osteoarthritis with the Kellgren & Lawrence Grade of ? ~III using standing, weightbearing, mild flexion, and posteroanterior X-ray within 3 months before the screening (based on -2 weeks) or at the screening visit 3. A patient failing to adequately respond to conservative non-drug therapy and/or simple analgesics (such as acetaminophen) 4. WOMAC-Likert pain subscore ranging from 7 to 17 at baseline visit 5. WOMAC-Likert pain score of 2 to 3 while walking on a flat surface 6. A patient who can walk without depending on a walking aid such as a walker, cane, etc. However, if the patient has been using a walking aid on a daily basis from 6 months ago, the patient assessment may be conducted including the walking aid, and the walking aid must be used in the same way until the clinical study is completed 7. A patient who can understand the efficacy measurement questionnaire well and complete it 8. A patient who has been informed of the purpose, method, effects, etc. of the clinical study and signed the written informed consent form 9. A patient who falls under one of the following three cases a. A patient who is surgically sterile b. A female patient over 45 years of age with menopause and who had the last menstruation more than 2 years ago c. A female patient of childbearing potential before menopause or male patient who is not surgically sterile should agree to use effective contraceptive methods during the clinical trial and within 26 weeks after final administration of the investigational product, such as: - Barrier methods: condom, diaphragm, cervical cap (pessary), spermicide - Hormonal methods: pills, injection (Depot), skin patch, hormonal implant (Implanon), vaginal ring - Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena) - Natural methods: basic body temperature, ovulation period, coitus interruptus, abstinent 10. A patient who discontinued analgesics, NSAIDs, physical therapy (electrotherapy, cryotherapy, laser, ultrasound, transcutaneous electrical nerve stimulation, etc.) or oriental medical treatment (acupuncture, cupping therapy, moxa treatment, etc.) within 2 weeks before the administration (washout period) and who is willing to discontinue them from the screening visit until the study is completed
Exclusion criteria
Exclusion criteria: 1. WOMAC-Likert pain question score > 3 in the contralateral (nonstudied) knee 2. Body mass index (kg/m2) > 32 3. A patient with rheumatoid arthritis or other inflammatory metabolic arthritis 4. A patient with infection at the joint such as septic arthritis 5. A patient with skin infection or skin disease at the injection area 6. A patient with secondary osteoarthritis caused by ochronosis, hemochromatosis, systemic disease, etc. 7. A patient with a very painful musculoskeletal disease such as Sudek’s atrophy, Paget’s disease and Spinal disc herniation 8. A patient with osteoarthritis in other areas (e.g. hip joint, etc.) which has a potential effect on knee pain assessment 9. A patient showing a clear loss in the joint space of patello-femoral joint (PFJ) in X-ray 10. A patient who took the following drug before the administration of the investigational product (baseline visit) a. A patient who was injected with HA in the target knee joint within the last 9 months b. A patient who was injected with steroids in the knee joint cavity within the last 6 months c. A patient who had taken systemic steroids in the last 3 months (excluding inhalants and topical agents that have a topical effect) d. A patient who began to take glucosamine, chondroitin and other nutritional supplements in the last 3 months or who changed his/her dose in the last 3 months or who was unable to maintain the same dose during the study 11. A patient with significant joint effusion or tested positive by patellar tap 12. A patient with alcohol intoxication and alcoholic liver disease 13. A patient whose blood pregnancy test result at the screening visit was positive, or a female patient in lactation 14. A patient with serious heart disease or hepatic and renal dysfunction or a patient who showed the following laboratory test value a. AST, ALT = 3 x ULN b. Bilirubin = 1.5 x ULN c. Serum creatinine = 1.5 x ULN 15. A patient who had a surgical procedure including arthroscopy in the target knee joint within the last 1 year (In case of a patient who had a joint surgery in the other knee joint or hip joint, the patient shall be excluded if the surgery is likely to affect the assessment of the target knee.) 16. A patient who had knee replacement surgery in the target knee joint 17. A patient who does highly intensive aerobic exercise, such as running or weight training which may affect the knee joint, or heavy anaerobic exercise 18. A patient who needs combined treatment with anticoagulant agent (excluding aspirin of dose less than 325 mg/day) 19. A patient who had depression, anxiety, insomnia or other diseases that may affect efficacy assessment based on the past medical history 20. A patient who has prior hypersensitive reactions to the investigational product of this clinical study (e.g. sodium hyaluronate, local anesthetics, acetaminophen, etc.) 21. A patient who is participating in other clinical studies after enrolling in this study, or who participated in other clinical studies within 3 months before the enrollment in this clinical study 22. A patient with any medically significant condition (e.g. other musculoskeletal diseases, malignancies, coagulopathy, immunodeficiency) that may affect the safety and effectiveness assessments and patient’s willingness to participate in the study in the opinion of the investigator 23. A patient who is considered to have difficulty in participating in the clinical study at the discretion of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Western Ontario and McMaster Universities Arthritis Index-Likert Pain Assessment at 13 Weeks after the Final Administration from Baseline Value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Western Ontario and McMaster Universities Arthritis Index-Likert Pain Assessment at 1, 6 and 26 Weeks after the Final Administration from Baseline Value;Change in the Western Ontario and McMaster Universities Arthritis Index-Likert Function Assessment at 1, 6, 13 and 26 Weeks after the Final Administration from Baseline Value;Change in the Western Ontario and McMaster Universities Arthritis Index-Likert Stiffness Assessment at 1, 6, 13 and 26 Weeks after the Final Administration from Baseline Value;Change in the Western Ontario and McMaster Universities Arthritis Index-Likert Total Score at 1, 6, 13 and 26 Weeks after the Final Administration from Baseline Value;Change in the Patient Global Assessment at 1, 6, 13 and 26 Weeks after the Final Administration from Baseline Value;Change in the Investigator Global Assessment at 1, 6, 13 and 26 Weeks after the Final Administration from Baseline Value;Physical assessment at each visit after final administration;Percentage (%) of subjects on rescue therapy at each visit after final administration;Outcome Measures in Rheumatology-Osteoarthritis Research Society International response rate;Adverse events;Clinical laboratory tests (clinical biochemistry);Vital signs;Physical examination;Drug consumption on rescue therapy at each visit after final administration;Clinical laboratory tests (hematology);Clinical laboratory tests (urinalysis); | — |
Countries
China
Contacts
Public ContactHong Cai
Peking University Third Hospital
Outcome results
None listed