A study comparing montelukast to placebo for reducing pain in patients with erosive osteoarthritis of the hands

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What is this study about?

This study is looking at a condition called erosive osteoarthritis of the hands, which is a form of joint disease that affects the fingers and can cause pain, swelling, and difficulty using the hands for daily activities. In this type of osteoarthritis, the joints become damaged and inflamed, making it harder to perform simple tasks like lifting objects. The study will test whether a medication called Montelukast can help reduce pain and improve hand function in people with this condition. Participants will receive either Montelukast in the form of hard capsules or a placebo, which means some people will get the actual medication while others will get an inactive treatment for comparison.

The purpose of this study is to find out if Montelukast is effective and safe for treating hand pain in people with erosive osteoarthritis of the hands. The researchers want to see if the medication can reduce pain intensity in the most affected hand after 24 weeks of treatment compared to placebo. Pain will be measured using a scale where participants mark how much pain they feel, ranging from no pain to the worst pain imaginable.

During the study, participants will take their assigned treatment for 24 weeks, which is about six months. Throughout this time, they will attend scheduled visits where doctors will check their pain levels and how well their hands are working. The study will compare the results between those taking Montelukast and those taking placebo to determine whether the medication makes a difference in reducing hand pain and improving the ability to use the hands for everyday tasks.

1 Baseline visit and treatment start

At the beginning of the study, your baseline measurements will be recorded. This includes assessing the pain intensity at rest in your most affected hand using a Visual Analogue Scale, which is a tool where you mark your pain level on a line from no pain to worst pain possible.

Your hand function will be evaluated using a questionnaire that asks about your ability to perform daily activities with your hands.

You will be randomly assigned to receive either Montelukast or placebo. Montelukast is the medication being tested, while placebo is an inactive substance that looks identical but contains no active ingredient. Neither you nor your doctor will know which one you are receiving, as this is a double-blind study.

You will receive hard capsules to take orally, meaning by mouth.

2 Treatment period

You will take the assigned treatment for 24 weeks, which is approximately 6 months.

The capsules should be taken as instructed by the study team.

During this period, you will need to attend scheduled visits to monitor your progress and assess how the treatment is working.

3 Follow-up visits and assessments

Throughout the 24-week treatment period, you will have regular visits where your pain levels will be measured again using the same Visual Analogue Scale.

Your hand function and ability to perform daily tasks will be evaluated at these visits.

Any side effects or changes in your health will be monitored and recorded to assess the safety of the treatment.

4 End of treatment assessment

At the end of the 24-week treatment period, a final assessment will be conducted.

Your pain intensity at rest in the most affected hand will be measured and compared to your baseline measurements from the start of the study.

Final evaluations of your hand function and overall condition will be completed.

Who Can Join the Study?

You must be willing to provide written permission to join the study and be able to attend all required visits and follow all study procedures.
You must be 18 years of age or older at the time of the first screening visit.
You must have erosive osteoarthritis in the finger joints of your hand, which is a type of joint damage that causes wearing away of cartilage and bone changes. This condition must be active and causing significant symptoms based on specific medical criteria.
You must have a pain level of at least 50 mm when your most affected hand is at rest, measured on a visual scale that goes from 0 to 100, where higher numbers mean more pain.
You must have difficulty using your most affected hand in daily activities, shown by answering with a score of at least 1 on a specific question about whether you can lift a full bottle with that hand.

Who Cannot Join the Study?

Pregnancy or breastfeeding: Women who are pregnant, planning to become pregnant during the study, or currently breastfeeding cannot participate
Severe liver problems: If you have serious disease affecting your liver that prevents it from working properly
Severe kidney problems: If you have serious disease affecting your kidneys that prevents them from working properly
Known allergy to Montelukast: If you have had an allergic reaction to the study medicine or any of its ingredients in the past
Other forms of arthritis: If you have rheumatoid arthritis, which is a different type of joint inflammation where the body’s immune system attacks the joints, or psoriatic arthritis, which is joint inflammation associated with a skin condition called psoriasis
Recent joint injections: If you have received injections of corticosteroids, which are anti-inflammatory medicines, into the hand joints within the last 3 months
Current use of certain medications: If you are taking medicines that might interfere with the study treatment, such as other anti-inflammatory drugs or pain medications that cannot be stopped during the study
Participation in other studies: If you are currently taking part in another clinical trial or have participated in one within the last 30 days
Serious uncontrolled medical conditions: If you have other severe health problems that are not well controlled, such as uncontrolled diabetes, heart disease, or cancer
Unable to follow study requirements: If you cannot attend regular study visits or follow the study procedures for any reason

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Hospital Del Mar	Barcelona	Spain
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Unidade Local De Saude Do Alto Minho E.P.E.	Ponte De Lima	Portugal
Hospital Hm Rosaleda Hm La Esperanza	Santiago De Compostela	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Quirón Salud Infanta Luisa	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)	Aveiro	Portugal
Ompfwypc Cuhdxm Pvxdh Copllsg	Velletri RM	Italy
Hocfpmdn Oj Szg Poetdf Fvrrlvhpyhleixnr	Rome	Italy
Psxp Thlaj Hqdpldjp Uopwifknrpsa	Sabadell	Spain
Hvwceyre Udbgabdkmzuur Mkwiw Thwbtixj	Terrassa	Spain
Arjckta Owvkqtpjdce Uxrioerjmreha Cxllcharvrfx Dyuzs Sxlfar E Diwxp Suuhqsg Dx Tbhink	Turin	Italy
Uajgvyhugf Dypvt Sulkg Dh Rzgw Le Shphhjyh	Rome	Italy
Fqclxwtjn Pxmr Ly Ilyunaegejrxx Bearueweo Dsr Hcajanxi Urpfjrwhklyzf Lw Pwa	Madrid	Spain
Hzgdpuyw Vsrg dpzmatfq	Barcelona	Spain
Hrbprjjb Ugmmgbpszrnib dh A Cbybdj	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	17.11.2025
Portugal	Recruiting	17.11.2025
Spain	Recruiting	17.11.2025

Trial locations

Investigated drugs:

Montelukast

Montelukast is a medication that is commonly used to treat asthma and allergies by reducing inflammation and swelling in the airways. In this clinical trial, it is being tested to see if it can help reduce pain and inflammation in patients who have a type of hand arthritis called erosive osteoarthritis. The researchers want to find out if this medication can make the pain in the affected hand better compared to a placebo, which is an inactive treatment with no medicine in it.

Investigated diseases:

Osteoarthritis

Erosive Osteoarthritis of the Hands – This is a form of osteoarthritis that specifically affects the joints of the fingers and hands, characterized by inflammation and erosion of the joint surfaces. The condition causes the cartilage that cushions the joints to break down more aggressively than in typical osteoarthritis, leading to bone damage and visible erosions on imaging. Patients experience pain, stiffness, and swelling in the affected hand joints, particularly in the finger joints closest to the fingernails and the middle joints of the fingers. The disease typically progresses through phases of inflammation followed by periods of relative calm, but the joint damage tends to worsen over time. As the condition advances, the joints may become deformed and lose their normal range of motion. This form of hand osteoarthritis is more destructive than the common non-erosive type and can significantly impact daily activities requiring hand function.

Trial ID:

2025-521802-17-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study comparing montelukast to placebo for reducing pain in patients with erosive osteoarthritis of the hands

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?