Observational Study of Synovian® Inj. in Patients With Os... | NCT04369261

Studies
Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee

NCT04369261

Sponsor

LG Chem

Status

Completed

Last Update Posted

Apr 30, 2020Actual

Enrollment

1,949Actual

Phase

Not provided

Conditions

Osteoarthritis in the Knee

Interventions

Synovian®

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2018Actual

Primary Completion Date

Aug 8, 2019Actual

Completion Date

Aug 8, 2019Actual

First Submitted Date

Apr 28, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2020

Last Update Posted Date

Apr 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,949Actual

Name	Type	Description	Arm Group Labels	Other Names
Synovian®	Drug	Synovian® Inj.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety endpoints	injection site reactions	Week 2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A patient from hospital and clinic as well

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University GURI Hospital		Guri-si	Gyeonggi-do	11923	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34192989	Derived	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.