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

Inclusion Criteria:

• Willing to participate in the study and provide written informed consent.

• Women of childbearing potential and sexually active must use an acceptablecontraceptive method (barrier and/or hormonal) as determined by the investigator.

• History of hyperuricemia diagnosis (uric acid > 7 mg/dL) reported in medical historyor patient interview.

• Clinical diagnosis of acute gouty arthritis with a score of at least 4 based on thefollowing 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 orat least one cardiovascular disease (1.5 points).

• Acute episode characterized by severe pain, inflammation, edema, and erythema in theaffected joint (≤ 48 hours before study inclusion).

• In the opinion of the Principal Investigator or treating physician, the patient iseligible for treatment with the investigational product and may benefit clinically

Exclusion Criteria:

• Patients participating in another clinical study involving an investigationaltreatment or participation in one within the two weeks prior to study initiation.

• Patients whose participation in the study may be influenced (e.g., employmentrelationship with the research center or sponsor, vulnerable populations, etc.).

• In the investigator's judgment, any condition that affects prognosis and preventsoutpatient management, which must be assessed by the principal investigator todetermine the patient's eligibility.

• History of severe, progressive, or unstable advanced disease of any kind that mayinterfere with efficacy and safety evaluations or put the patient at risk.

• Pregnant or breastfeeding patients.

• The study medication is contraindicated for medical reasons.

• History of intolerance or allergic reaction to NSAIDs (nonsteroidalanti-inflammatory drugs), paracetamol, or known hypersensitivity to any component ofthe formulation.

• Significant history of gastrointestinal disorders (e.g., gastric ulcer, Crohn'sdisease, ulcerative colitis, gastrointestinal bleeding, etc.).

• History of congestive heart failure (NYHA classification II-IV), establishedischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization orangioplasty).

• Treatment with systemic corticosteroids for the management of acute gouty arthritiswithin two weeks before study initiation.

• Treatment with NSAIDs within 48 hours prior to study initiation, except for aspirinat cardioprotective doses.

• History of treatment failure with selective COX-2 inhibitors, as reported in medicalhistory or patient interview.

• Presence of acute polyarticular gout affecting more than four joints.

• History of alcohol or drug abuse within the past year.

• Clinical suspicion of joint infection or another joint disease different from acutegouty arthritis.

• History of chronic liver failure (Child-Pugh A, B, and/or C), as reported in medicalhistory or patient interview.

• History of chronic renal failure (glomerular filtration rate <30 ml/min/1.73 m²), asreported 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 inmedical history or patient interview.

• Oncology patients (except for basal cell skin cancer) or patients with severediseases that, in the investigator's opinion, have a severe prognosis or a lifeexpectancy 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 orconfirmed COVID-19 case.