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New pill aims to ease knee pain without being worse than current drug

NCT ID NCT07203547

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

40 to 80 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The official record

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