Knee OsteoarthritisPhase 2NCT06954766
Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981
A Phase 2 study testing CKD-981(1), CKD-981(2) and Reference Drug in people with Knee Osteoarthritis, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CKD-981(1), CKD-981(2) and Reference Drug
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2025to 28 Oct 2025
- Phase
- Phase 2
- 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
- Patients between 40 years and 80 years old
- Patients who have experiencing knee pain more than 8 weeks
- VAS more than 40 mm
- Kellgren and Lawrence grade 2 and 3 in X' ray knee joint
Who cannot join
- Previous knee surgery in affected side
- Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease
- Infection of knee joint
- BMI more than 35kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Sham-controlled, Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981 in Patients With Degenerative Knee Osteoarthritis
The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981
Read the detailed description
The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks
- Conditions
- Knee Osteoarthritis
- Being tested
- CKD-981(1), CKD-981(2), Sham device, Reference Drug, Placebo Drug
- Keywords
- CKD-981
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-981(1)Device
Also called Expermental Device 1
20 minutes per day, 5 days a week for 6 weeks.
CKD-981(2)Device
Also called Expermental Device 2
20 minutes per day, 5 days a week for 6 weeks.
Sham deviceDevice
Also called CKD-981 Sham Device
20 minutes per day, 5 days a week for 6 weeks.
Reference DrugDrug
Also called NSAIDs
QD for 6 weeks
Placebo DrugDrug
Also called Placebo for NSAIDs
QD for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Expermental group 1 | Experimental | Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo. Receives: Device: CKD-981(1); Drug: Placebo Drug |
| Expermental group 2 | Experimental | Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo. Receives: Device: CKD-981(2); Drug: Placebo Drug |
| Sham group | Sham comparator | Patients assigned to this group will receive treatment with the sham device in combination with a placebo. Receives: Device: Sham device; Drug: Placebo Drug |
| Reference group | Sham comparator | Patients assigned to this group will receive treatment with the sham device in combination with a reference drug. Receives: Device: Sham device; Drug: Reference Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: 6 Weeks
Secondary outcomes (2)
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: 2 weeks, 4 weeks
Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline
The K-WOMAC consists of 24 items, with each item scored on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), where higher scores indicate greater symptom severity
Measured: 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start28 Apr 2025
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954766
- Sponsor's protocol ID
- A145_01OA2401
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Sham-controlled, Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981 in Patients With Degenerative Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06954766
- Acronym / sponsor ID
- A145_01OA2401
- Conditions
- Knee Osteoarthritis
- Keywords
- CKD-981
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 2 May 2025 (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.
The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981
Detailed description
The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Expermental group 1 | Experimental | Device: CKD-981(1), Drug: Placebo DrugPatients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo. |
| Expermental group 2 | Experimental | Device: CKD-981(2), Drug: Placebo DrugPatients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo. |
| Sham group | Sham comparator | Device: Sham device, Drug: Placebo DrugPatients assigned to this group will receive treatment with the sham device in combination with a placebo. |
| Reference group | Sham comparator | Device: Sham device, Drug: Reference DrugPatients assigned to this group will receive treatment with the sham device in combination with a reference drug. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 40 years and 80 years old
- Patients who have experiencing knee pain more than 8 weeks
- VAS more than 40 mm
- Kellgren and Lawrence grade 2 and 3 in X' ray knee joint
Key exclusion criteria (4 listed)
- Previous knee surgery in affected side
- Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease
- Infection of knee joint
- BMI more than 35kg/m2
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 |
|---|---|---|
| CKD-981(1)Also: Expermental Device 120 minutes per day, 5 days a week for 6 weeks. | Device | Expermental group 1 |
| CKD-981(2)Also: Expermental Device 220 minutes per day, 5 days a week for 6 weeks. | Device | Expermental group 2 |
| Sham deviceAlso: CKD-981 Sham Device20 minutes per day, 5 days a week for 6 weeks. | Device | Reference group, Sham group |
| Reference DrugAlso: NSAIDsQD for 6 weeks | Drug | Reference group |
| Placebo DrugAlso: Placebo for NSAIDsQD for 6 weeks | Drug | Expermental group 1, Expermental group 2, Sham group |
Primary outcome
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
Time frame: 6 Weeks
Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)
2 secondary outcomes
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
Time frame: 2 weeks, 4 weeks
Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline
Time frame: 2 weeks, 4 weeks, 6 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 13 Apr 2026.
- 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 Phase 2 study testing CKD-981(1), CKD-981(2) and Reference Drug in people with Knee Osteoarthritis, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 4 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 13 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS) (time frame: 6 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 13 Apr 2026.