FindTrial
Sign In

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06954766
Enrollment
100
Registered
2025-05-02
Start date
2025-04-28
Completion date
2025-10-28
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

CKD-981

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

Interventions

DEVICECKD-981(1)

20 minutes per day, 5 days a week for 6 weeks.

DEVICECKD-981(2)

20 minutes per day, 5 days a week for 6 weeks.

DEVICESham device

20 minutes per day, 5 days a week for 6 weeks.

DRUGReference Drug

QD for 6 weeks

DRUGPlacebo Drug

QD for 6 weeks

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)6 WeeksPain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)

Secondary

MeasureTime frameDescription
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)2 weeks, 4 weeksPain 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 baseline2 weeks, 4 weeks, 6 weeksThe 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026