Efficacy and Safety of DKM420 in Patients With Osteoarthr... | NCT06021444

Studies
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

NCT06021444

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Sep 21, 2023Actual

Enrollment

250Actual

Phase

Not Applicable

Conditions

Osteoarthritis of Knee

Interventions

DKM420
Conjuran

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2020Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Jul 18, 2023Actual

First Submitted Date

Apr 17, 2023

First Submission Date that Met QC Criteria

Aug 28, 2023

First Posted Date

Sep 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2023

Last Update Posted Date

Sep 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DKM420	Experimental	Injecting to one side knee.	Device: DKM420
Conjuran	Active Comparator	Injecting to one side knee.	Device: Conjuran

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DKM420	Device	A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.	DKM420

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
100mm VAS(Visual Analogue Scale)	Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
100mm VAS(Visual Analogue Scale)	Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)	2, 8 weeks
K-WOMAC(Korean Western Ontario and McMaster Universities)	Change(Score from 0 to 96, the lower the better.)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
chung-Ang University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided