Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee
A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee
1 other identifier
observational
1,949
1 country
1
Brief Summary
This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedFirst Submitted
Initial submission to the registry
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedApril 30, 2020
April 1, 2020
1.4 years
April 28, 2020
April 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
safety endpoints
injection site reactions
Week 2
Interventions
Synovian® Inj.
Eligibility Criteria
A patient from hospital and clinic as well
You may qualify if:
- Adult male or female patient of over 19 years of age
- A patient diagnosed with knee osteoarthritis
- A patient who has been informed of the purpose, method of the study and signed the written informed consent form.
You may not qualify if:
- A patient who shows hypersensitive reaction to the Synovian® Inj. or to the ingredients of Synovian® Inj.
- A patient with infection at the joint
- A patient with skin infection or skin disease at the injection area
- A patient diagnosed with osteoarthritis with the Kellgren \& Lawrence Grade IV in X-ray within 12 months before enrollment of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
Study Sites (1)
Hanyang University GURI Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Related Publications (1)
Jang KM, Park YG, Choi WK, Chung YY, Kim KK, Lee JW, Lee SJ, Eom Y, Yang JH. Safety of a single intra-articular injection of LBSA0103 hyaluronic acid in patients with osteoarthritis of the knee: a multicenter, single-arm, prospective, cohort study. Curr Med Res Opin. 2021 Sep;37(9):1573-1580. doi: 10.1080/03007995.2021.1950132. Epub 2021 Jul 15.
PMID: 34192989DERIVED
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2020
First Posted
April 30, 2020
Study Start
March 9, 2018
Primary Completion
August 8, 2019
Study Completion
August 8, 2019
Last Updated
April 30, 2020
Record last verified: 2020-04