Etoricoxib and Betamethasone for treating acute gout arthritis

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

This study is testing whether a combination of Etoricoxib and Betamethasone can help people with acute gout arthritis feel less pain compared to just using Etoricoxib alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laboratorios Silanes S.A. de C.V. (Industry-sponsored)
• Locations: 1 site (Mexico City)
• Trial ID: NCT06863701 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of a fixed-dose combination of Etoricoxib and Betamethasone compared to Etoricoxib alone in patients suffering from acute gouty arthritis. Participants will be randomized into two groups and monitored over an 8-day follow-up period to assess pain levels in the affected joint. Adverse events related to the treatments will also be recorded during this time. The study aims to provide insights into the effectiveness of this combination therapy for managing acute gout attacks.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with acute gouty arthritis who have a history of hyperuricemia and meet specific clinical criteria.

Not a fit: Patients who do not have a clinical diagnosis of acute gouty arthritis or those with contraindications to Etoricoxib or Betamethasone may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve recovery times for patients experiencing acute gout attacks.

How similar studies have performed: Other studies have shown promising results with similar combinations of anti-inflammatory medications for gout, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Patients participating in another clinical study involving an investigational treatment or participation in one within the two weeks prior to study initiation.
* Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.).
* 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.
* Pregnant or breastfeeding patients.
* The study medication is contraindicated for medical reasons.
* 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).
* 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.
* History of treatment failure with selective COX-2 inhibitors, as reported in medical history 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 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.

Where this trial is running

Mexico City

• Laboratorio Silanes, S.A. de C.V. — Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: Rafael Lanuza-Ramirez, MD — Consultorio Médico "Dr. Rodrigo Suárez Otero"
• Study coordinator: Jorge A Gonzalez, PhD

Conditions Gout Arthritis; Gout Attack; Etoricoxib; Betamethasone