Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee
April 28, 2020 updated by: LG Chem
A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee
This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee
Study Overview
Study Type
Observational
Enrollment (Actual)
1949
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gyeonggi-do
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Guri-si, Gyeonggi-do, Korea, Republic of, 11923
- Hanyang University Guri Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A patient from hospital and clinic as well
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
safety endpoints
Time Frame: Week 2
|
injection site reactions
|
Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2018
Primary Completion (Actual)
August 8, 2019
Study Completion (Actual)
August 8, 2019
Study Registration Dates
First Submitted
April 28, 2020
First Submitted That Met QC Criteria
April 28, 2020
First Posted (Actual)
April 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 30, 2020
Last Update Submitted That Met QC Criteria
April 28, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-HAOS006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
not decided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.