Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial
- Registration Number
- NCT05930080
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SKCPT group SKCPT - Celebrex group Celebrex -
- Primary Outcome Measures
Name Time Method K-WOMAC Pain Subscale 84 days 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
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of