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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
Dongkook Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 17, 2023
Last Updated
September 18, 2023
Sponsor
Dongkook Pharmaceutical Co., Ltd.
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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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