Phase 4 Study of Laybon Tab. in Knee Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorMather's Pharm. Co., Ltd.
About this trial
This Phase 4, multicenter, randomized, double-blind, active-controlled, parallel study aims to evaluate the non-inferiority of Laybon Tab. compared to Layla Tab. (PMG Pharm Co., Ltd.) in patients with knee osteoarthritis. Participants will receive either Laybon Tab. or Layla Tab. for 8 weeks. The primary outcome is the change in knee pain during activity, assessed by a 100 mm pain VAS over the previous 24 hours.
Eligibility criteria
Qualifiers
Adults aged 40 to 80 years, male or female.
Age > 50 years
Morning stiffness < 30 minutes
Crepitus
Disqualifiers
Screening BMI ≥ 35.0 kg/m².
Rheumatoid arthritis, autoimmune diseases, septic arthritis, inflammatory joint diseases, gout, recurrent pseudogout, joint fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrodysplasia, genetic disorders (e.g., hypermobility), or secondary osteoarthritis
Severe osteoarthritis of hip or other joints interfering with knee evaluation
Painful conditions such as Sudeck's atrophy, Paget's disease, spinal disc herniation
Trial design
Treatments tested in this trial
- Layla Tab.
- Laybon Tab.
Treatment groups
172 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov