NCT05930080CompletedPhase 3
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis
SK Chemicals Co., Ltd.1 site in 1 country278 target enrollmentStarted: January 28, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- K-WOMAC Pain Subscale
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
SKCPT group
Experimental
Intervention: SKCPT (Drug)
Celebrex group
Active Comparator
Intervention: Celebrex (Drug)
Outcomes
Primary Outcomes
K-WOMAC Pain Subscale
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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