Status:
UNKNOWN
A Post Marketing Surveillance Study of INVOSSA K Inj.
Lead Sponsor:
Kolon Life Science
Conditions:
Osteoarthritis
Eligibility:
All Genders
19+ years
Brief Summary
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.
Eligibility Criteria
Inclusion
- Male or female patients over 19 years
- Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :
- \- Moderate knee osteoarthritis (Kellgren \& Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months
- Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form
Exclusion
- Pregnant or breastfeeding female
- Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
- Patients who have severe disease such as heart, liver, kidney disease or other severe complications
- Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
- Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
- Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months
- Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof
- Patients with Kellgran \& Lawrence grade 4 osteoarthritis
Key Trial Info
Start Date :
July 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 11 2023
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT03412864
Start Date
July 12 2017
End Date
July 11 2023
Last Update
May 28 2019
Active Locations (1)
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1
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do, South Korea, 42415