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

Status

Completed

Conditions

Intervention / Treatment

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

  • Korea, Republic of
    • Gyeonggi-do
      • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital

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

LG Chem

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.

General Publications

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.

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