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

SK chemicals

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis, Knee

Treatments

Drug: SKCPT

Drug: Celebrex

Study type

Interventional

Funder types

Industry

Identifiers

NCT05930080

SKCPT_001

Details and patient eligibility

About

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

Enrollment

278 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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