Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis

Trial details

Who runs it

Laboratorios Silanes S.A. de C.V.

Trial code

NCT06863701

Record updated

3 April 2025

Original description

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Betamethasone Versus Etoricoxib in Patients With Acute Gouty ArthritisRead full original descriptionShow less

Efficacy and Safety Study for the Combination of Etoricoxib / Betamethasone Compared to Etoricoxib for the Treatment of Patients Diagnosed With Acute Gout Arthritis

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Betamethasone Versus Etoricoxib in Patients With Acute Gouty Arthritis

Inclusion: Willing to participate in the study and provide written informed consent; Women of childbearing potential and sexually active must use an acceptable contraceptive method (barrier and/or hormonal) as determined by the investigator; History of hyperuricemia diagnosis (uric acid > 7 mg/dL) reported in medical history or patient interview; Clinical diagnosis of acute gouty arthritis with a score of at least 4 based on the following criteria: Male (2 points), history of a similar episode (2 points), symptom onset within the last 24 hours (0.5 points), joint redness (1 point), involvement of the first metatarsophalangeal joint (2.5 points), and hypertension or at least one cardiovascular disease (1.5 points); Acute episode characterized by severe pain, inflammation, edema, and erythema in the affected joint (≤ 48 hours before study inclusion); In the opinion of the Principal Investigator or treating physician, the patient is eligible for treatment with the investigational product and may benefit clinically.

Exclusion: Patients participating in another clinical study involving an investigational treatment or participation in one within the two weeks prior to study initiation; The study medication is contraindicated for medical reasons; Treatment with systemic corticosteroids for the management of acute gouty arthritis within two weeks before study initiation; Treatment with NSAIDs within 48 hours prior to study initiation, except for aspirin at cardioprotective doses; In the investigator's judgment, any condition that affects prognosis and prevents outpatient management, which must be assessed by the principal investigator to determine the patient's eligibility; History of severe, progressive, or unstable advanced disease of any kind that may interfere with efficacy and safety evaluations or put the patient at risk; History of intolerance or allergic reaction to NSAIDs (nonsteroidal anti-inflammatory drugs), paracetamol, or known hypersensitivity to any component of the formulation; Significant history of gastrointestinal disorders (e.g., gastric ulcer, Crohn's disease, ulcerative colitis, gastrointestinal bleeding, etc.); History of congestive heart failure (NYHA classification II-IV), established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization or angioplasty); History of treatment failure with selective COX-2 inhibitors, as reported in medical history or patient interview; History of alcohol or drug abuse within the past year; Clinical suspicion of joint infection or another joint disease different from acute gouty arthritis; History of chronic liver failure (Child-Pugh A, B, and/or C), as reported in medical history or patient interview; History of chronic renal failure (glomerular filtration rate <30 ml/min/1.73 m²), as reported in medical history or patient interview; Significant history of known coagulation disorders (e.g., Von Willebrand disease, hemophilia, vitamin K deficiency, etc.) or use of anticoagulants, as reported in medical history or patient interview; Oncology patients (except for basal cell skin cancer) or patients with severe diseases that, in the investigator's opinion, have a severe prognosis or a life expectancy of less than one year, as well as patients with mental illnesses; Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, shortness of breath) and/or contact within the last 14 days with a suspected or confirmed COVID-19 case; Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.); Pregnant or breastfeeding patients; Presence of acute polyarticular gout affecting more than four joints.

ClinicalTrials.gov NCT06863701