Actively Recruiting
Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2025-04-03
72
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 specified criteria including male gender, prior similar episode, recent symptom onset, joint redness, first metatarsophalangeal joint involvement, and cardiovascular history.
- Acute episode characterized by severe pain, inflammation, edema, and erythema in the affected joint within 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
You will not qualify if you...
- Participation in another clinical study involving investigational treatment within two weeks before study start.
- Participation influenced by employment or vulnerable population status.
- Any condition affecting prognosis or preventing outpatient management as judged by the investigator.
- History of severe, progressive, or unstable advanced disease that may interfere with study evaluations or risk patient safety.
- Pregnant or breastfeeding patients.
- Contraindications to study medication for medical reasons.
- History of intolerance or allergic reaction to NSAIDs, paracetamol, or any component of the formulation.
- Significant gastrointestinal disorders such as gastric ulcer, Crohn's disease, ulcerative colitis, or gastrointestinal bleeding.
- History of congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
- Treatment with systemic corticosteroids for acute gouty arthritis within two weeks before study start.
- Treatment with NSAIDs within 48 hours before study start, except low-dose aspirin.
- History of treatment failure with selective COX-2 inhibitors.
- Acute polyarticular gout affecting more than four joints.
- History of alcohol or drug abuse within the past year.
- Clinical suspicion of joint infection or other joint diseases different from acute gouty arthritis.
- History of chronic liver failure (Child-Pugh A, B, or C).
- History of chronic renal failure with low glomerular filtration rate (<30 ml/min/1.73 m²).
- Significant coagulation disorders or use of anticoagulants.
- Oncology patients (except basal cell skin cancer), severe diseases with poor prognosis, or mental illnesses.
- Symptoms suggestive of active COVID-19 infection or recent contact with a COVID-19 case within 14 days.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
Research Team
J
Jorge A Gonzalez, PhD
CONTACT
Y
Yulia Romero-Antonio, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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