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Completed

NCT Number: NCT06954766

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wonju Severance Christian Hospital

Wŏnju, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-981(1)

Device

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

Other names: Expermental Device 1

CKD-981(2)

Device

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

Other names: Expermental Device 2

Sham device

Device

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

Other names: CKD-981 Sham Device

Reference Drug

Drug

QD for 6 weeks

Other names: NSAIDs

Placebo drug

Drug

QD for 6 weeks

Other names: Placebo for NSAIDs

Primary outcomes

  1. Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)

    Time frame: 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 outcomes

  1. Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)

    Time frame: 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)

  2. Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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