Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981

Phase 2

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: CKD-981(1); Device: CKD-981(2); Device: Sham device; Drug: Placebo Drug; Drug: Reference Drug

• Registration Number: NCT06954766
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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 Timeline

• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Status Verified: 2025-05
• Study First Posted: 2025-05-02
• Last Update Submitted: 2025-05-09
• Study Start: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expermental group 1	CKD-981(1)	Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
Expermental group 1	Placebo Drug	Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
Expermental group 2	CKD-981(2)	Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
Expermental group 2	Placebo Drug	Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
Sham group	Sham device	Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
Sham group	Placebo Drug	Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
Reference group	Sham device	Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.
Reference group	Reference Drug	Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.

Primary Outcome Measures

Name	Time	Method
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)	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)

Secondary Outcome Measures

Name	Time	Method
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)	2 weeks, 4 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)
Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline	2 weeks, 4 weeks, 6 weeks	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

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of