Study on Montelukast for Pain Relief in Patients with Erosive Hand Osteoarthritis

What is this study about?

This clinical trial is focused on studying the effects of the medication Montelukast in patients with a condition known as erosive osteoarthritis of the hands. This type of osteoarthritis involves the breakdown of cartilage in the joints of the hands, leading to pain and swelling. The study will explore how different doses of Montelukast, which is a type of medication called a leukotriene receptor antagonist, can help manage the pain associated with this condition. Montelukast is being tested in various forms, including Montelukast A, B, C, and D, with doses ranging from 5 mg to 30 mg. A placebo will also be used for comparison.

The purpose of the study is to evaluate the difference in pain intensity in the most affected hand after 8 weeks of treatment with Montelukast compared to a placebo. Participants will take the medication in the form of hard capsules by mouth. The study will last for a total of 8 weeks, during which participants will be monitored for changes in pain levels, hand function, and overall quality of life. The study will also assess the safety of Montelukast by checking vital signs and any side effects that may occur.

Throughout the study, participants will be asked to report their pain levels using a tool called the Visual Analogue Scale (VAS), which helps measure pain intensity. Additionally, the study will look at how Montelukast affects hand grip strength and the use of any additional pain relief medication. The goal is to find the most effective dose of Montelukast for reducing pain and improving hand function in patients with erosive osteoarthritis of the hands.

1 joining the study

Upon joining the study, the patient provides written informed consent, confirming willingness to comply with all scheduled visits and procedures.

Eligibility is confirmed based on criteria such as age (18 years or older), diagnosis of erosive osteoarthritis of the hands, and specific pain and functionality assessments.

2 baseline assessment

The baseline assessment includes measuring pain intensity of the most affected hand using the Visual Analogue Scale (VAS).

Functionality of the hand is evaluated using the AUSCAN Questionnaire, focusing on tasks like carrying a full pot with one hand.

3 treatment phase

The patient receives one of the following treatments: Montelukast in doses of 5, 10, 15, or 30 mg, or a placebo. The medication is administered orally in the form of hard capsules.

The treatment duration is 8 weeks, with regular monitoring of pain intensity and hand functionality.

4 midpoint evaluation

At 4 weeks, the patient undergoes an evaluation to measure changes in pain intensity and hand functionality compared to baseline.

Additional assessments include hand grip strength and the use of any rescue medication.

5 final evaluation

At 8 weeks, a final evaluation is conducted to assess the difference in pain intensity and hand functionality from baseline.

The patient’s quality of life and any sleeping difficulties due to hand pain are also evaluated.

6 safety monitoring

Throughout the study, safety is monitored through regular checks of vital signs, physical examinations, and laboratory tests.

Any adverse events are recorded and analyzed to ensure patient safety.

Who Can Join the Study?

Patients must provide written informed consent, which means they agree to participate in the study and understand what it involves.
Patients must be 18 years or older at the time of the first visit.
Patients must have erosive osteoarthritis of the hand joints. This is a type of arthritis that affects the small joints in the fingers and causes damage.
Patients must have a pain level of 50 mm or more on a Visual Analogue Scale (VAS). This is a tool used to measure pain intensity, where 0 means no pain and 100 means the worst pain imaginable.
Patients must have difficulty using their most affected hand, specifically scoring 2 or more on a question about carrying a full pot with one hand from the AUSCAN Questionnaire. This questionnaire assesses hand function.

Who Cannot Join the Study?

Patients who have any other type of arthritis besides erosive osteoarthritis of the hands. This means if you have a different form of joint inflammation, you cannot participate.
Patients who are currently taking medications that might interfere with the study. This means if you are on certain drugs that could affect the results, you cannot join.
Patients with severe medical conditions that could make participation unsafe. This means if you have a serious health issue that could be risky, you cannot be part of the study.
Patients who are pregnant or breastfeeding. This means if you are expecting a baby or nursing, you cannot take part in the study.
Patients who have participated in another clinical trial recently. This means if you have been part of a different study not long ago, you cannot join this one.
Patients with known allergies to Montelukast or similar medications. This means if you have had allergic reactions to this drug or similar ones, you cannot participate.
Patients who are unable to follow the study procedures. This means if you cannot comply with the study’s requirements, you cannot be part of it.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Quirón Salud Infanta Luisa	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Hospital Del Mar	Barcelona	Spain
Pdpb Tzndv Hzdshwlx Uhxxdmnxpoen	Sabadell	Spain
Hqwhbucl Uaxqnqkuzfrxk Mkmta Toxldjvq	Terrassa	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	15.11.2023

Trial locations

Investigated drugs:

Montelukast

Montelukast is a medication being studied for its potential to reduce pain in patients with erosive osteoarthritis of the hands. This trial aims to find the most effective dose of Montelukast for alleviating pain in the affected hand. Montelukast is typically used to manage asthma and allergies, but in this study, it is being tested for its ability to relieve joint pain and inflammation associated with osteoarthritis.

Investigated diseases:

Osteoarthritis

Erosive Osteoarthritis of the Hands – Erosive osteoarthritis of the hands is a form of osteoarthritis characterized by the breakdown of cartilage in the joints of the hands, leading to pain and inflammation. This condition often results in the formation of bony growths and can cause significant discomfort and stiffness in the affected joints. Over time, the disease may lead to visible deformities in the fingers and reduced hand function. The progression of erosive osteoarthritis can vary, with periods of increased symptoms followed by times of relative stability. It primarily affects middle-aged and older adults, with a higher prevalence in women. The exact cause is not fully understood, but it is believed to involve a combination of genetic, environmental, and lifestyle factors.

Trial ID:

2023-506137-30-00

Protocol code:

FMLD-ARSIDOS-55_FII

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Montelukast for Pain Relief in Patients with Erosive Hand Osteoarthritis

What is this study about?

Who Can Join the Study?

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