Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

September 18, 2023 updated by: Dongkook Pharmaceutical Co., Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DKM420
Injecting to one side knee.
Device: DKM420
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
Active Comparator: Conjuran
Injecting to one side knee.
Device: Conjuran
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, 8 weeks
K-WOMAC(Korean Western Ontario and McMaster Universities)
Time Frame: 2, 8, 16 weeks
Change(Score from 0 to 96, the lower the better.)
2, 8, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 18, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKM-420-MD-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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