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

April 10, 2026 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Wŏnju, South Korea
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expermental group 1
Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
Device: CKD-981(1)
20 minutes per day, 5 days a week for 6 weeks.
Other Names:
  • Expermental Device 1
Drug: Placebo Drug
QD for 6 weeks
Other Names:
  • Placebo for NSAIDs
Experimental: Expermental group 2
Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
Device: CKD-981(2)
20 minutes per day, 5 days a week for 6 weeks.
Other Names:
  • Expermental Device 2
Drug: Placebo Drug
QD for 6 weeks
Other Names:
  • Placebo for NSAIDs
Sham Comparator: Sham group
Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
Device: Sham device
20 minutes per day, 5 days a week for 6 weeks.
Other Names:
  • CKD-981 Sham Device
Drug: Placebo Drug
QD for 6 weeks
Other Names:
  • Placebo for NSAIDs
Sham Comparator: Reference group
Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.
Device: Sham device
20 minutes per day, 5 days a week for 6 weeks.
Other Names:
  • CKD-981 Sham Device
Drug: Reference Drug
QD for 6 weeks
Other Names:
  • NSAIDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks, 4 weeks
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
2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Actual)

October 28, 2025

Study Completion (Actual)

October 28, 2025

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A145_01OA2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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