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Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SKCPT
Celebrex
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult males and females aged 20 to 75 years Kellgren-Lawrence (KL) grade 1 to 3 Individuals who voluntarily decide to participate in the study and provide written informed consent form Individuals who can understand and follow instructions and can participate in the study during the entire study period Exclusion Criteria: Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint Individuals who have undergone knee joint arthroplasty Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SKCPT group

Celebrex group

Arm Description

Outcomes

Primary Outcome Measures

K-WOMAC Pain Subscale
The average changes in the K-WOMAC(Western Ontario and McMasters Universitis) Pain Subscale (range: 0-100 mm, higher scores mean a worse outcome)

Secondary Outcome Measures

Full Information

First Posted
June 20, 2023
Last Updated
July 3, 2023
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05930080
Brief Title
Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial
Official Title
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKCPT group
Arm Type
Experimental
Arm Title
Celebrex group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SKCPT
Intervention Description
the randomly assigned subjects took the study drug for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Celebrex
Intervention Description
the randomly assigned subjects took the study drug for 12 weeks
Primary Outcome Measure Information:
Title
K-WOMAC Pain Subscale
Description
The average changes in the K-WOMAC(Western Ontario and McMasters Universitis) Pain Subscale (range: 0-100 mm, higher scores mean a worse outcome)
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult males and females aged 20 to 75 years Kellgren-Lawrence (KL) grade 1 to 3 Individuals who voluntarily decide to participate in the study and provide written informed consent form Individuals who can understand and follow instructions and can participate in the study during the entire study period Exclusion Criteria: Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint Individuals who have undergone knee joint arthroplasty Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial

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