Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981
Key facts
- Who runs it
- Chong Kun Dang Pharmaceutical
- Where
- South Korea1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 100 people enrolled
- Started
- 28 Apr 2025
- Ended
- 28 Oct 2025
- Type of study
- Interventional, 4 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- CKD-981(1)
- CKD-981(2)
- Sham device
- Reference Drug
- Placebo Drug
- Record updated
- 13 April 2026
Who can take part
- Age
- 40 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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 take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981
The 4 groups in the trial
- Expermental group 1Treatment being tested
Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
Treatment: CKD-981(1) and Placebo Drug
- Expermental group 2Treatment being tested
Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
Treatment: CKD-981(2) and Placebo Drug
- Sham groupSham treatment, for comparison
Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
Treatment: Sham device and Placebo Drug
- Reference groupSham treatment, for comparison
Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.
Treatment: Sham device and Reference Drug
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 13 April 2026