Efficacy and Safety Evaluation of Montelukast Versus Placebo in Patients with Erosive Hand Osteoarthritis: A Randomized, Double-Blind, Multicenter Trial
- Trial ID
- 2025-521802-17-00
- Sponsor
- Farmalider S.A.
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of montelukast compared to placebo in reducing pain intensity at rest in the most affected hand of patients diagnosed with erosive hand osteoarthritis. This assessment is performed using the Visual Analogue Scale (VAS) at 24 weeks of treatment relative to baseline. 5, 3
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients diagnosed with erosive osteoarthritis of the interphalangeal joints of the hand. Participants must be at least 18 years of age at the time of screening. Inclusion requires the presence of significant clinical activity according to the Anandarajah criteria. Eligible individuals must exhibit a pain intensity at rest of at least 50 mm on the Visual Analogue Scale in the most affected hand. Additionally, patients must demonstrate functional impairment in the most affected hand, defined by a score of 1 or greater on the fourth item of the FIHOA questionnaire.
Plans and Procedures
This randomised, multicentre, double-blind, controlled trial is designed to evaluate the efficacy and safety of montelukast compared to a placebo in patients diagnosed with erosive osteoarthritis of the hands. The study utilizes a Phase III therapeutic exploratory and confirmatory methodology. The primary endpoint is the change in pain intensity at rest of the most affected hand, measured via the Visual Analogue Scale, compared to baseline after 24 weeks of treatment. The study sequence begins with a screening visit to assess eligibility based on age, clinical activity according to Anandarajah criteria, and functional impairment measured by the FIHOA questionnaire. Following successful screening, participants will undergo a treatment period lasting 24 weeks, which includes scheduled follow-up visits to monitor safety and efficacy. The trial concludes with an end-of-study visit. Total participant involvement is expected to span the treatment duration and associated clinical assessments.
Treatment
The experimental medication consists of montelukast administered in the form of hard capsules. This substance is intended for oral administration.
The control group receives a placebo as a comparator treatment.
Efficacy
The primary efficacy endpoint is the difference in pain intensity at rest of the most affected hand compared to baseline. This assessment is conducted at 24 weeks of treatment to evaluate the comparative effect of montelukast against placebo in patients with erosive osteoarthritis of the hands. The Visual Analogue Scale is utilized as the instrument to measure this parameter.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patients who provide written informed consent (IC) and are able to comply with all scheduled visits and procedures required by the study.
- Patients ≥ 18 years at the screening visit.
- Patients with erosive osteoarthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah criteria (Anandarajah, A. 2010).
- Patients with VAS pain at rest of the most affected hand ≥ 50 mm at baseline visit.
- Patients with repercussion in functionality of the most affected hand evaluated with a score ≥1 in the question number 4 (Are you able to lift a full bottle with the hand?) of the FIHOA questionnaire at baseline visit.
Exclusion Criteria
- History of fibromyalgia and/or chronic fatigue syndrome.
- Patient being treated with any other medication contraindicated due to risk of interactions with study medication.
- Patient being treated with NSAIDs and/or analgesics (except paracetamol) or colchicine within 7 days prior to the baseline visit. The use of paracetamol will be allowed up to 24 hours prior to the start of study treatment.
- Patient with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients.
- Patient intolerant to study medication due to galactose intolerance, lactase insufficiency, or glucose-galactose malabsorption.
- Pregnant or lactating women.
- Women of childbearing age and sexually active (excluded from this definition are women whose date of last menstruation is greater than one year from inclusion in this study and those who have undergone a tubal ligation or hysterectomy), who do not agree to take acceptable contraceptive measures during the clinical trial. Contraceptive measures include barrier methods, hormonal contraception, intrauterine device (IUD), or sexual abstinence. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
- Patient currently included in or who have participated in a clinical trial with medicines or health products in the 3 months prior to the baseline visit.
- Patients with scheduled surgery during the clinical trial.
- History of drug or alcohol abuse during the 12 months prior to the baseline visit.
- Patients with any contraindication related to the performance of the MRI test, including: • Pacemakers or neurostimulators, • Metal plates or fragments not attached to the bone in risk areas, newly implanted heart valves or intracranial clips. • Claustrophobia. • Weight more than 120 kg. • Intolerance to paramagnetic contrast.
- Patient with pathologies that according to medical criteria discourage their participation in the study, such as severe heart disease, liver failure, kidney failure, active malignancies, poorly controlled endocrine-metabolic diseases, coagulopathies, active gastrointestinal ulceration, active infection, epilepsy, and immunocompromised patients.
- Patients who, in the opinion of the investigator, are unable or not willing to comply with study and follow-up procedures.
- Patient with a history of concurrent rheumatic articular diseases (history and/or current presence of signs) that could lead to a misinterpretation or interfere in the evaluation of efficacy in pain, such as chondrocalcinosis, Paget's disease of the ipsilateral extremity in relation to the affected hand, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis and disease Inflammatory bowel (Crohn's disease or Ulcerative Colitis).
- Patient with a BMI ≥ 35 kg/m2.
- Pain in another part of the body that could interfere with the evaluation and results of the study according to investigator criteria.
- Patient taking corticosteroids (oral or injectable) within 4 weeks prior to the baseline visit, or methotrexate, hydroxychloroquine or SYSADOAs (Slow-Acting Drugs for the Symptomatic Treatment of Osteoarthritis) within 12 weeks prior to the baseline visit.
- Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the baseline visit.
- Patient undergoing radioactive synoviorthesis (in the study hand).
- Patient being treated with other disease-modifying anti-rheumatic biological drugs.
- Patient with poorly controlled neuropsychiatric diseases evaluated with a score ≥ 10 in PHQ-9 questionnaire or score diferent than 0 in question 9 “Thoughts that you would be better off dead or of hurting yourself in some way”.
- Patients undergoing physical therapy or active physical rehabilitation (individual or group) treatment, are exposed to electrotherapy procedures or physical therapies, including specifically: Magnetotherapy, Therapeutic Ultrasound, Transcutaneous Electrical Stimulation (TENS), during the entire period of study participation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Italy | Not Yet Recruiting | 17 Nov 2025 | 40 |
 Portugal | Recruiting | 17 Nov 2025 | 24 |
 Spain | Recruiting | 17 Nov 2025 | 96 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Montelukast C | Test | HARD CAPSULES | ORAL | 0 | 24 | PRD9539479 |
Placebo | Placebo | N/A | — | — | — | N/A |