Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981
NCT ID: NCT06954766
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-05-12
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Expermental group 1
Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
CKD-981(1)
20 minutes per day, 5 days a week for 6 weeks.
Placebo Drug
QD for 6 weeks
Expermental group 2
Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
CKD-981(2)
20 minutes per day, 5 days a week for 6 weeks.
Placebo Drug
QD for 6 weeks
Sham group
Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
Sham device
20 minutes per day, 5 days a week for 6 weeks.
Placebo Drug
QD for 6 weeks
Reference group
Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.
Sham device
20 minutes per day, 5 days a week for 6 weeks.
Reference Drug
QD for 6 weeks
Interventions
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CKD-981(1)
20 minutes per day, 5 days a week for 6 weeks.
CKD-981(2)
20 minutes per day, 5 days a week for 6 weeks.
Sham device
20 minutes per day, 5 days a week for 6 weeks.
Reference Drug
QD for 6 weeks
Placebo Drug
QD for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease
* Infection of knee joint
* BMI more than 35kg/m2
40 Years
80 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A145_01OA2401
Identifier Type: -
Identifier Source: org_study_id
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