NCT06021444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

April 17, 2023

Last Update Submit

September 18, 2023

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

  • 100mm VAS(Visual Analogue Scale)

    Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)

    16 weeks

Secondary Outcomes (2)

  • 100mm VAS(Visual Analogue Scale)

    2, 8 weeks

  • K-WOMAC(Korean Western Ontario and McMaster Universities)

    2, 8, 16 weeks

Study Arms (2)

DKM420

EXPERIMENTAL

Injecting to one side knee.

Device: DKM420

Conjuran

ACTIVE COMPARATOR

Injecting to one side knee.

Device: Conjuran

Interventions

DKM420DEVICE

A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.

DKM420
ConjuranDEVICE

A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.

Conjuran

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • mm VAS(Visual Analogue Scale) over 40mm.
  • Etc.

You may not qualify if:

  • \- Pregnancy and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

chung-Ang University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
1. Blind: Investigator 2. Un-blind: Investigator(or CRC).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 Parallel.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

September 1, 2023

Study Start

December 30, 2020

Primary Completion

June 1, 2023

Study Completion

July 18, 2023

Last Updated

September 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)