Health TrialsbyHealthPanel

Phase 4 Study of Laybon Tab. in Knee Osteoarthritis

ConditionsOsteoarthritis, KneeOsteoarthritis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Layla Tab.

    Drug

    Layla Tab., oral, twice daily, 8 weeks.

  • Laybon Tab.

    Drug

    Laybon Tab., oral, twice daily, 8 weeks.

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: Test Drug GroupExperimental treatment 1 intervention
Group B: Control Drug GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and Week 8

Secondary outcomes

1

Change From Baseline in Knee Pain During Activity (100 mm Pain VAS) at Week 4

Change from baseline (Visit 2) to Week 4 in activity-related knee pain over the past 24 hours, assessed by 100 mm pain VAS.

Time frame
Baseline and Week 4
2

Change From Baseline in WOMAC Total Score

Change from baseline (Visit 2) to Week 4 and Week 8 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score.

Time frame
Baseline, week 4 and week 8
3

Change From Baseline in WOMAC Subscale Scores

Change from baseline (Visit 2) to Week 4 and Week 8 in WOMAC subscale scores: pain, stiffness, and physical function.

Time frame
Baseline, Week 4, and Week 8
4

Patient Global Assessment of Knee Osteoarthritis

Patient's global assessment of overall knee osteoarthritis symptoms using a 5-Point Likert Scale at Week 4 and Week 8.

Time frame
Week 4 and Week 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mather's Pharm. Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: