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

Osteoarthritis in the Knee Clinical Trial

Official title:

A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369261
• Other study ID #: LG-HAOS006
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: April 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1949
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis in the Knee

Intervention

Drug:
• Synovian®
Synovian® Inj.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University GURI Hospital	Guri-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety endpoints	injection site reactions	Week 2