AzTrials
AzTrials

Osteoarthritis, KneePhase 4NCT07203547

Phase 4 Study of Laybon Tab. in Knee Osteoarthritis

A Phase 4 study testing Layla Tab. and Laybon Tab. in people with Osteoarthritis, Knee and Osteoarthritis, run by Mather's Pharm. Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis, Knee, Osteoarthritis
What is being tested?
Layla Tab. and Laybon Tab.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
No sites listed yet
Study dates
Dec 2025to Mar 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 40 to 80 years, male or female.
  • Diagnosed with unilateral or bilateral knee osteoarthritis according to the American College of Rheumatology (ACR) clinical criteria, meeting at least 3 of the following:
  • Age > 50 years
  • Morning stiffness < 30 minutes
  • Crepitus
  • Bony tenderness
Show all 17Show fewer
  • Bony enlargement
  • No warmth on palpation
  • Knee osteoarthritis pain persisting for at least 3 months and requiring pharmacologic treatment at screening.
  • Kellgren-Lawrence grade 1-3 on knee X-ray at screening.
  • Knee pain during activity over the past 24 hours ≤ 80 mm on 100 mm pain VAS at screening.
  • Knee pain during activity over the past 24 hours ≥ 40 mm on 100 mm pain VAS at baseline (Visit 2).
  • Able to walk without assistance (walker, cane, etc.). Participants who have routinely used mobility aids for at least 6 months prior to screening may continue their usual aid throughout the study.
  • Women of childbearing potential and men must agree to use medically acceptable contraception during the study, including hormonal contraception, IUD/IUS, bilateral tubal ligation, partner vasectomy, or sexual abstinence.
  • Participants currently receiving treatment for knee osteoarthritis must agree to discontinue prior therapies and comply with a wash-out period before and during study participation
  • Participants must have received and understood a full explanation of the study and voluntarily provided written informed consent.
  • Women of childbearing potential must have a negative pregnancy test prior to study drug administration.

Who cannot join

  • Screening BMI ≥ 35.0 kg/m².
  • Presence of other joint disorders or systemic conditions that could affect safety or efficacy assessments, including:
  • 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
  • Active or suspected infection in the target knee
Show all 42Show fewer
  • History of the following conditions at screening:
  • Upper gastrointestinal ulcer within 6 months, GI bleeding within 12 months, or gastrointestinal disorders affecting drug absorption
  • Severe cardiovascular diseases (NYHA class ≥3, ischemic heart disease, arrhythmia, peripheral vascular disease, prior coronary interventions, cerebrovascular disorders)
  • Severe liver impairment (ALT or AST > 3× ULN)
  • Severe renal impairment (eGFR < 30 mL/min)
  • Bronchial asthma
  • Fluid retention
  • Lipid metabolism disorders (hyperlipidemia, diabetic dyslipidemia, pancreatitis)
  • Active systemic infection or viral infection (HCV, HBV)
  • Malignancy, except those in complete remission ≥5 years or certain completely treated cancers (basal cell carcinoma, squamous cell carcinoma, thyroid papillary carcinoma, cervical carcinoma in situ)
  • Current use of psychotropic medications.
  • History of knee interventions prior to study drug administration:
  • Cell or gene therapy, autologous bone marrow stem cell therapy within 5 years
  • Knee ligament surgery, cartilage graft, osteotomy within 1 year
  • Arthroscopy within 6 months
  • Intra-articular injections (HA, PN, PDRN, PRP, collagen, dextrose/prolotherapy) within 6 months
  • Steroid injections, other anti-inflammatory injections, unknown knee medications within 3 months
  • Continuous opioid use ≥1 week within 3 months
  • Systemic steroids (excluding inhaled) or anticonvulsants within 1 month
  • Prior knee joint replacement
  • Individuals who have received the following medications or therapies for the purpose of controlling pain or improving symptoms in the knee joint or other conditions prior to study drug administration and who are unable to discontinue these treatments during participation in the clinical trial, or who have additional treatments planned. (However, subjects may participate in the study after a 2-week wash-out period prior to study drug administration [Visit 2]. Low-dose aspirin up to 100 mg per day is permitted; the use of acetaminophen provided as rescue medication is allowed within the permitted dose, except within 48 hours prior to Visits 3 and 4.)
  • Acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and other analgesics.
  • Topical anti-inflammatory drugs for knee application (NSAID gel, cream, patch, etc.) or topical analgesics (including muscle pain relievers containing capsaicin, menthol, camphor, etc.).
  • Other therapies (e.g., physical therapy, oriental medicine such as acupuncture, cupping, and moxibustion).
  • Nutritional supplements for osteoarthritis (e.g., glucosamine, chondroitin, methylsulfonylmethane [MSM], boswellia, etc.).
  • Known hypersensitivity to study drug or rescue medications or their components.
  • History of allergy or hypersensitivity to COX-2 inhibitors, sulfonamides, aspirin, or other NSAIDs.
  • Pregnant or breastfeeding women.
  • Known allergy or hypersensitivity to soybean oil.
  • Known allergy or hypersensitivity to peanuts or legumes.
  • History of drug or alcohol abuse within 1 year prior to study drug administration.
  • High-risk alcohol consumption (≥2 times/week and ≥7 drinks per occasion for men, ≥5 for women).
  • Prior use of Layla Tab., Laybon Tab., or any herbal/extract product containing the same components (e.g., 25% ethanol extract of listed herbs) within the past 4 weeks (wash-out required).
  • Participation in another clinical trial or use of investigational medical device within 1 month prior to screening.
  • Unable to understand or provide informed consent as judged by the investigator.
  • Any other reason the investigator considers the participant unsuitable for study participation.

About this study

Official title: 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

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.

Read the 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.

Being tested
Layla Tab., Laybon Tab.
Keywords
Laybon Tab., Knee Osteoarthritis, Osteoarthritis, OA, Non-inferiority, Randomized Trial, Double blind, Phase 4
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Layla Tab.Drug

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

  • Laybon Tab.Drug

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

Study groups in NCT07203547
Study groupRoleWhat they receive
Test Drug GroupExperimentalNot described
Receives: Drug: Laybon Tab.
Control Drug GroupActive comparatorNot described
Receives: Drug: Layla Tab.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and Week 8

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Week 4 and Week 8

  5. Quality of Life Assessment Using SF-36

    Change in health-related quality of life measured by the SF-36 questionnaire at Week 4 and Week 8.

    Measured: Week 4 and Week 8

  6. Use of Rescue Medication

    Frequency and total amount of rescue medication used during the 8-week treatment period, evaluated at Week 4 and Week 8.

    Measured: Week 4 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07203547
Sponsor's protocol ID
MTS-RAY-401
Status last verified
Sep 2025
First submitted
24 Sep 2025
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Layla Tab. and Laybon Tab. in people with Osteoarthritis, Knee and Osteoarthritis, run by Mather's Pharm. Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Knee Pain During Activity (100 mm Pain VAS) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in