Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06021444

Enrollment

250

Registered

2023-09-01

Start date

2020-12-30

Completion date

2023-07-18

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of Knee

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

Interventions

DEVICEDKM420

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

DEVICEConjuran

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Masking description

1. Blind: Investigator 2. Un-blind: Investigator(or CRC).

Intervention model description

1:1 Parallel.

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026