Osteoarthritis, Knee
Conditions
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
Interventions
DRUGSKCPT
the randomly assigned subjects took the study drug for 12 weeks
DRUGCelebrex
the randomly assigned subjects took the study drug for 12 weeks
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed