Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
Not Applicable
Completed
- Conditions
- Osteoarthritis of Knee
- Interventions
- Device: DKM420Device: Conjuran
- Registration Number
- NCT06021444
- Lead Sponsor
- Dongkook Pharmaceutical Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- 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 Criteria
- Pregnancy and lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DKM420 DKM420 Injecting to one side knee. Conjuran Conjuran Injecting to one side knee.
- Primary Outcome Measures
Name Time Method 100mm VAS(Visual Analogue Scale) 16 weeks Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
- Secondary Outcome Measures
Name Time Method 100mm VAS(Visual Analogue Scale) 2, 8 weeks Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
K-WOMAC(Korean Western Ontario and McMaster Universities) 2, 8, 16 weeks Change(Score from 0 to 96, the lower the better.)
Trial Locations
- Locations (1)
chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of