Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

Dongkook Pharmaceutical

Status: Completed

Conditions: Osteoarthritis of Knee

Treatments: Device: DKM420; Device: Conjuran

Study type: Interventional

Funder types: Industry

Identifiers

NCT06021444

DKM-420-MD-1

Details and patient eligibility

About

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.

Full description

A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study

Enrollment: 250 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

DKM420

Experimental group

Description:

Injecting to one side knee.

Treatment:

Device: DKM420

Conjuran

Active Comparator group

Description:

Injecting to one side knee.

Treatment:

Device: Conjuran