Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981
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
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 knee-osteoarthritis
Started Apr 2025
Shorter than P25 for phase_2 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2025
CompletedStudy Start
First participant enrolled
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2025
CompletedApril 13, 2026
May 1, 2025
6 months
April 24, 2025
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
6 Weeks
Secondary Outcomes (2)
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
2 weeks, 4 weeks
Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline
2 weeks, 4 weeks, 6 weeks
Study Arms (4)
Expermental group 1
EXPERIMENTALPatients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
Expermental group 2
EXPERIMENTALPatients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
Sham group
SHAM COMPARATORPatients assigned to this group will receive treatment with the sham device in combination with a placebo.
Reference group
SHAM COMPARATORPatients assigned to this group will receive treatment with the sham device in combination with a reference drug.
Interventions
20 minutes per day, 5 days a week for 6 weeks.
QD for 6 weeks
20 minutes per day, 5 days a week for 6 weeks.
20 minutes per day, 5 days a week for 6 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2025
First Posted
May 2, 2025
Study Start
April 28, 2025
Primary Completion
October 28, 2025
Study Completion
October 28, 2025
Last Updated
April 13, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share