NCT07203547

Phase 4 Study of Laybon Tab. in Knee Osteoarthritis

Multicenter, Randomized, Double-blind, Active Control, Parallel, Non-inferior, Phase 4 Clinical Trial to Assess Efficacy and Safety of Laybon Tab. in Patients With Knee Osteoarthritis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Mather's Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This phase 4 clinical trial will assess the efficacy and safety of Laybon Tab. compared to Layla Tab. in adults with knee osteoarthritis. Participants will be randomized in a double-blind, parallel, active-controlled design to receive either Laybon Tab. or Layla Tab. for 8 weeks. The primary endpoint is the change in activity-related knee pain over the past 24 hours, measured by a 100 mm visual analogue scale (VAS). Secondary endpoints include additional efficacy and safety evaluations. The study aims to demonstrate the non-inferiority of Laybon Tab. to Layla Tab. All participants will be monitored for efficacy, safety, and medication compliance, and standard eligibility criteria will be applied.

Conditions

• Osteoarthritis, Knee
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Layla Tab.	Layla Tab., oral, twice daily, 8 weeks.
DRUG	Laybon Tab.	Laybon Tab., oral, twice daily, 8 weeks.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2025-10-02
• Last updated: 2025-10-02