Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
Primary Purpose
Osteoarthritis of Knee
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DKM420
Conjuran
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
Eligibility Criteria
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
Sites / Locations
- chung-Ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DKM420
Conjuran
Arm Description
Injecting to one side knee.
Injecting to one side knee.
Outcomes
Primary Outcome Measures
100mm VAS(Visual Analogue Scale)
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
Secondary Outcome Measures
100mm VAS(Visual Analogue Scale)
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
K-WOMAC(Korean Western Ontario and McMaster Universities)
Change(Score from 0 to 96, the lower the better.)
Full Information
NCT ID
NCT06021444
First Posted
April 17, 2023
Last Updated
September 18, 2023
Sponsor
Dongkook Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06021444
Brief Title
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
Official Title
A Multi-center, Randomized, Double-blind, Active-controlled, Pivotal, Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of 'DKM420' in Knee Osteoarthritis Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongkook Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Parallel.
Masking
Care ProviderOutcomes Assessor
Masking Description
Blind: Investigator
Un-blind: Investigator(or CRC).
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DKM420
Arm Type
Experimental
Arm Description
Injecting to one side knee.
Arm Title
Conjuran
Arm Type
Active Comparator
Arm Description
Injecting to one side knee.
Intervention Type
Device
Intervention Name(s)
DKM420
Intervention Description
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
Intervention Type
Device
Intervention Name(s)
Conjuran
Intervention Description
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
Primary Outcome Measure Information:
Title
100mm VAS(Visual Analogue Scale)
Description
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
100mm VAS(Visual Analogue Scale)
Description
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
Time Frame
2, 8 weeks
Title
K-WOMAC(Korean Western Ontario and McMaster Universities)
Description
Change(Score from 0 to 96, the lower the better.)
Time Frame
2, 8, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
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