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Completed

NCT Number: NCT06021444

Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

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.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

chung-Ang University Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DKM420

Device

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

Conjuran

Device

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

Primary outcomes

  1. 100mm VAS(Visual Analogue Scale)

    Time frame: 16 weeks

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

Secondary outcomes

  1. 100mm VAS(Visual Analogue Scale)

    Time frame: 2, 8 weeks

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

  2. K-WOMAC(Korean Western Ontario and McMaster Universities)

    Time frame: 2, 8, 16 weeks

    Change(Score from 0 to 96, the lower the better.)

Sponsors and collaborators

Lead sponsor

Dongkook Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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