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NCT06021444 Clinical Trial

Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

Osteoarthritis of Knee Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06021444
Other study ID # DKM-420-MD-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 30, 2020
Est. completion date July 18, 2023

Study information
Verified date August 2023
Source Dongkook Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date July 18, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 (?~?) at Visit 1 or within 24 weeks. - 100mm VAS(Visual Analogue Scale) over 40mm. - Etc. Exclusion Criteria: - Pregnancy and lactating women

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• DKM420
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
• Conjuran
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.

Locations
Country Name City State
Korea, Republic of chung-Ang University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 100mm VAS(Visual Analogue Scale) Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.) 16 weeks
Secondary 100mm VAS(Visual Analogue Scale) Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.) 2, 8 weeks
Secondary K-WOMAC(Korean Western Ontario and McMaster Universities) Change(Score from 0 to 96, the lower the better.) 2, 8, 16 weeks
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