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Tests treatment safety and results for Gout Arthritis
Official title Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis
ClinicalTrials.gov ID: NCT06863701
What this study is testing
What is Etoricoxib + Betamethasone fixed dose?
Etoricoxib + Betamethasone fixed dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gout arthritis.
Also referred to as Etori + Beta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Acute episode characterized by severe pain, inflammation, edema, and erythema in the affected joint (≤ 48 hours before study inclusion).
You likely can't join if
- Patients participating in another clinical study involving an investigational treatment or participation in one within the two weeks prior to study...
- Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable...
- In the investigator's judgment, any condition that affects prognosis and prevents outpatient management, which must be assessed by the principal...
- History of severe, progressive, or unstable advanced disease of any kind that may interfere with how well it works and safety evaluations or put the...
- Pregnant or breastfeeding patients.
- The study medication is contraindicated for medical reasons.
See the full eligibility 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)...
- 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
- 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 how well it works 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.