Osteoarthritis in the KneeNCT04369261
Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee
An observational study of Osteoarthritis in the Knee, run by LG Chem at 1 site in South Korea.
Trial summary
This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis in the Knee
- What is being tested?
- Synovian®
- How many people
- 1,949 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2018to 8 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A patient from hospital and clinic as well
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University GURI Hospital
Guri-si, Gyeonggi-do, 11923
About this study
Official title: 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
- Conditions
- Osteoarthritis in the Knee
- Being tested
- Synovian®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovian®Drug
Synovian® Inj.
What is being measured
The primary outcome is the main question the study is designed to answer.
safety endpoints
injection site reactions
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start9 Mar 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis in the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,949 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369261
- Sponsor's protocol ID
- LG-HAOS006
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided
Publications
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.
PubMed 34192989
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee
- ClinicalTrials.gov ID
- NCT04369261
- Acronym / sponsor ID
- LG-HAOS006
- Conditions
- Osteoarthritis in the Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,949 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient from hospital and clinic as well
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synovian®Synovian® Inj. | Drug | – |
Primary outcome
safety endpoints
Time frame: Week 2
injection site reactions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Derived from this study: PubMed 34192989Jang 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.
- Individual participant dataSharing planned: Undecided. not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis in the Knee, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety endpoints (time frame: Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.