Status:
UNKNOWN
The Efficacy and Safety of Invossa K Injection in Patients Diagnosed With Knee Osteoarthritis
Lead Sponsor:
Kolon Life Science
Conditions:
Osteoarthritis
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Male or female aged 19 and older
- Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.
- Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.
- Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- BMI should fall between 18.5 and 30
- Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology guidelines, and applies to one of the following.
- Age \> 50 years old
- Morning stiffness \< 30 minutes
- Crepitus and Osteophytes
- With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- Patients with persistent symptoms in spite of conservative therapy for more than 3 months : Improvement of 100 mm VAS are less than 10 mm after 3 months
- Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
- Agreed to use an effective contraceptive method during the study period
- Voluntarily agreed to participate in this study, and signed the informed consent form
Exclusion
- Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- Patients with severe pain in other areas that could effect the diagnosis of the symptoms
- Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- History of surgery like arthroendoscopy within the past 6 months on the target knee
- Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
- History of injection within the past 3 months on the target knee
- Pregnant or breastfeeding female
- With another joint disease apart from degenerative arthritis
- Patients with hepatitis including carrier
- Patients with HIV and an infectious disease which is clinically uncontrolled
- Patients who have any of the following clinically significant diseases or have a medical history within 6 months :
- Clinically significant heart diseases which are considered by the investigator
- Uncontrolled hypertension : if the systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg in a sitting position
- Kidney disease
- Liver disease
- Endocrine disease
- Uncontrolled diabetes mellitus : HbA1c ≥ 9%
- Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease
- Genetic diseases (hyperkinesia, collagen gene abnormality)
- Medical history of past or current malignant tumor
- Patients with a history of anaphylactic reactions
- Patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide, mannitol, dextran 40 or bovine proteins
- Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- Patients who administered the INVOSSA K inj.
- Considered inappropriate by the investigator for participation in this study
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2020
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03383471
Start Date
February 12 2018
End Date
March 30 2020
Last Update
March 7 2018
Active Locations (17)
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1
Korea University Anam Hospital
Ansan, South Korea
2
Inje University Busan Paik Hospital
Busan, South Korea
3
Kyungpook National University School of Medicine
Daegu, South Korea
4
Chungnam National University School of Medicine
Daejeon, South Korea