Status:
COMPLETED
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
Lead Sponsor:
Dongkook Pharmaceutical Co., Ltd.
Conditions:
Osteoarthritis of Knee
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM 420 and control for patients who have osteoarthritis of Knee.
Detailed Description
A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study
Eligibility Criteria
Inclusion
- Men and Women who is over 40 under 80 ages.
- Diagnosed as osteoarthritis of Knee and satisfies the 3 of 6 ACR(American College of Rheumatology) conditions.
- Kellgren Lawrence grade (Ⅰ\~Ⅲ) at Visit 1 or within 24 weeks.
- 100mm VAS(Visual Analogue Scale) over 40mm.
- Etc.
Exclusion
- \- Pregnancy and lactating women
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06021444
Start Date
December 30 2020
End Date
July 18 2023
Last Update
September 21 2023
Active Locations (1)
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1
chung-Ang University Hospital
Seoul, South Korea