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
Sponsor study identifier
interventional
172
0 countries
N/A
Study Start
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2025
Actual (reported)October 2, 2025
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change From Baseline in Knee Pain During Activity (100 mm Pain VAS)
Change from baseline (Visit 2, prior to study drug administration) to Week 8 in activity-related knee pain over the past 24 hours, as assessed by a 100 mm pain Visual Analogue Scale (VAS).
Baseline and Week 8
Change From Baseline in Knee Pain During Activity (100 mm Pain VAS) at Week 4
Baseline and Week 4
Change From Baseline in WOMAC Total Score
Baseline, week 4 and week 8
Layla Tab., oral, twice daily, 8 weeks.
Laybon Tab., oral, twice daily, 8 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
September 24, 2025
First Posted
October 2, 2025
Study Start
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Change From Baseline in WOMAC Subscale Scores
Baseline, Week 4, and Week 8
Patient Global Assessment of Knee Osteoarthritis
Week 4 and Week 8
Quality of Life Assessment Using SF-36
Week 4 and Week 8
Contact the study team to confirm eligibility.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 2, 2025
Record last verified: 2025-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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