New pill aims to ease knee pain without being worse than current drug
NCT ID NCT07203547
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a new tablet called Laybon is as good as an existing drug (Layla) at reducing knee pain from osteoarthritis. About 172 adults aged 40-80 with knee osteoarthritis will take either Laybon or Layla twice daily for 8 weeks. The main goal is to see if knee pain during activity improves similarly with both treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Laybon Tab. (oral tablet)
- What this could lead to
- If it works, this could offer a new treatment option for knee osteoarthritis pain that is as effective as existing medications.
- What could go wrong
- This is a non-inferiority trial, so it may only show that Laybon is no worse than the active control, not that it works better. The study is small (172 people) and short (8 weeks), so long-term benefits or risks are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 172 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults aged 40 to 80 years, male or female. 2. 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 * Bony enlargement * No warmth on palpation 3. Knee osteoarthritis pain persisting for at least 3 months and requiring pharmacologic treatment at screening. 4. Kellgren-Lawrence grade 1-3 on knee X-ray at screening. 5. Knee pain during activity over the past 24 hours ≤ 80 mm on 100 mm pain VAS at screening. 6. Knee pain during activity over the past 24 hours ≥ 40 mm on 100 mm pain VAS at baseline (Visit 2). 7. 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. 8. 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. 9. 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 10. Participants must have received and understood a full explanation of the study and voluntarily provided written informed consent. 11. Women of childbearing potential must have a negative pregnancy test prior to study drug administration. Exclusion Criteria: 1. Screening BMI ≥ 35.0 kg/m². 2. 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 3. 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) 4. Current use of psychotropic medications. 5. 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 6. 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.). 7. Known hypersensitivity to study drug or rescue medications or their components. 8. History of allergy or hypersensitivity to COX-2 inhibitors, sulfonamides, aspirin, or other NSAIDs. 9. Pregnant or breastfeeding women. 10. Known allergy or hypersensitivity to soybean oil. 11. Known allergy or hypersensitivity to peanuts or legumes. 12. History of drug or alcohol abuse within 1 year prior to study drug administration. 13. High-risk alcohol consumption (≥2 times/week and ≥7 drinks per occasion for men, ≥5 for women). 14. 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). 15. Participation in another clinical trial or use of investigational medical device within 1 month prior to screening. 16. Unable to understand or provide informed consent as judged by the investigator. 17. Any other reason the investigator considers the participant unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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