Osteoarthritis of KneeNCT06021444
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
A study testing DKM420 and Conjuran in people with Osteoarthritis of Knee, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- DKM420 and Conjuran
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2020to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study
- Conditions
- Osteoarthritis of Knee
- Being tested
- DKM420, Conjuran
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKM420Device
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
ConjuranDevice
A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DKM420 | Experimental | Injecting to one side knee. Receives: Device: DKM420 |
| Conjuran | Active comparator | Injecting to one side knee. Receives: Device: Conjuran |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm VAS(Visual Analogue Scale)
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
Measured: 16 weeks
Secondary outcomes (2)
100mm VAS(Visual Analogue Scale)
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
Measured: 2, 8 weeks
K-WOMAC(Korean Western Ontario and McMaster Universities)
Change(Score from 0 to 96, the lower the better.)
Measured: 2, 8, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start30 Dec 2020
- Primary completion1 Jun 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Parallel.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021444
- Sponsor's protocol ID
- DKM-420-MD-1
- Status last verified
- Aug 2023
- First submitted
- 17 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06021444
- Acronym / sponsor ID
- DKM-420-MD-1
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 Parallel.
| Arm | Type | Receives |
|---|---|---|
| DKM420 | Experimental | Device: DKM420Injecting to one side knee. |
| Conjuran | Active comparator | Device: ConjuranInjecting to one side knee. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKM420A total of 3 doses will be applied at a dose of 2 mL over 3 weeks. | Device | DKM420 |
| ConjuranA total of 3 doses will be applied at a dose of 2 mL over 3 weeks. | Device | Conjuran |
Primary outcome
100mm VAS(Visual Analogue Scale)
Time frame: 16 weeks
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
2 secondary outcomes
100mm VAS(Visual Analogue Scale)
Time frame: 2, 8 weeks
K-WOMAC(Korean Western Ontario and McMaster Universities)
Time frame: 2, 8, 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DKM420 and Conjuran in people with Osteoarthritis of Knee, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm VAS(Visual Analogue Scale) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.