Phase 4 Study of Laybon Tab. in Knee Osteoarthritis

Sponsor
Mather's Pharm. Co., Ltd.
Study ID
NCT07203547
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Layla Tab. — DRUG
    Layla Tab., oral, twice daily, 8 weeks.
  • Laybon Tab. — DRUG
    Laybon Tab., oral, twice daily, 8 weeks.

Study Details

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.

Key Dates

First listed
Oct 2, 2025
Start date
Dec 31, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Drug Group
  • Active Comparator: Control Drug Group

Primary Outcome Measure

Change From Baseline in Knee Pain During Activity (100 mm Pain VAS) [ Time Frame: Baseline and Week 8 ]

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