A randomized, multi-centre, double-blind, phase II clinical trial of dose finding of Montelukast in patients with erosive osteoarthritis of the hands. HOME study.

A vizsgálat adatai

Ki végzi

Farmalider S.A.

Azonosító

EU 2023-506137-30-00

A regiszteradat frissítve

2023. november 6.

Eredeti leírás

The primary objective of the study is to evaluate the difference in pain intensity of the most affected hand at 8 weeks of treatment with different doses of Montelukast, compared to placebo, in patients with erosive hand osteoarthritis (EHOA), using the Visual Analogue Scale (VAS).A teljes eredeti leírásKevesebb

The primary objective of the study is to evaluate the difference in pain intensity of the most affected hand at 8 weeks of treatment with different doses of Montelukast, compared to placebo, in patients with erosive hand osteoarthritis (EHOA), using the Visual Analogue Scale (VAS).

Bevonási feltételek: Patients who provide written informed consent and are willing to comply with all scheduled visits and procedures required by the study; Patients ≥ 18 years at the time of the baseline visit; Patients with erosive osteoarthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah criteria; Patients with VAS pain of the most affected hand ≥ 50 mm at the baseline visit; Patients with repercussion in functionality of the most affected hand evaluated with a score ≥2 in the question number 12 (carrying a full pot with one hand) of the function subscale of the AUSCAN Questionnaire.

Kizáró feltételek: 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. *The sporadic use of Ibuprofen in case of an intercurrent disease other than EHOA will be allowed up to 96 hours prior to the screening visit (visit 0), or, to the visit 1. Maximum daily dose of ibuprofen allowed will be 1200mg; 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; 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 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 being treated with other disease-modifying anti-rheumatic biological drugs; Patient being treated with any other medication contraindicated due to risk of interactions with study medication; History of fibromyalgia and/or chronic fatigue syndrome; Patient with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients; Patient with pathologies that according to medical criteria discourage their participation in the study, such as poorly controlled neuropsychiatrics diseases, severe heart disease, liver failure, kidney failure, active malignancies, poorly controlled endocrine-metabolic diseases, coagulopathies, active gastrointestinal ulceration, active infection, epilepsy, and immunocompromised patients; Patient intolerant to study medication due to galactose intolerance, lactase insufficiency, or glucose-galactose malabsorption; 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 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; Pregnant or lactating women; Pain in another part of the body that could interfere with the evaluation and results of the study according investigator criteria; Patient undergoing radioactive synoviorthesis (in the study hand).

EU CTIS 2023-506137-30-00