Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

NCT ID: NCT06021444

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2023-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 Parallel.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DKM420

Injecting to one side knee.

Group Type EXPERIMENTAL

DKM420

Intervention Type DEVICE

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

Conjuran

Injecting to one side knee.

Group Type ACTIVE_COMPARATOR

Conjuran

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DKM420

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

Intervention Type DEVICE

Conjuran

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dongkook Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DKM-420-MD-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.