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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369261
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
LG Chem

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

Condition or disease Intervention/treatment
Osteoarthritis in the Knee Drug: Synovian®

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Study Type : Observational
Actual Enrollment : 1949 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : August 8, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis


Intervention Details:
  • Drug: Synovian®
    Synovian® Inj.


Primary Outcome Measures :
  1. safety endpoints [ Time Frame: Week 2 ]
    injection site reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A patient from hospital and clinic as well
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369261


Locations
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Korea, Republic of
Hanyang University GURI Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 11923
Sponsors and Collaborators
LG Chem
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04369261    
Other Study ID Numbers: LG-HAOS006
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases