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

Osteoarthritis, Knee 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930080
• Other study ID #: SKCPT_001
• Status: Completed
• Phase: Phase 3
• Start date: January 28, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2023
• Source: SK Chemicals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: September 30, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• SKCPT
the randomly assigned subjects took the study drug for 12 weeks
• Celebrex
the randomly assigned subjects took the study drug for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	84 days