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

Chong Kun Dang

Status and phase: Enrolling; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Device: CKD-981(1); Drug: Reference Drug; Drug: Placebo Drug; Device: Sham device; Device: CKD-981(2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06954766

A145_01OA2401

Details and patient eligibility

About

The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Expermental group 1

Experimental group

Description:

Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.

Treatment:

Drug: Placebo Drug

Device: CKD-981(1)

Expermental group 2

Experimental group

Description:

Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.

Treatment:

Device: CKD-981(2)

Drug: Placebo Drug

Sham group

Sham Comparator group

Description:

Patients assigned to this group will receive treatment with the sham device in combination with a placebo.

Treatment:

Device: Sham device

Drug: Placebo Drug

Reference group

Sham Comparator group

Description:

Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.

Treatment:

Device: Sham device

Drug: Reference Drug