NCT06863701

Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Researchers will compare the fixed-dose combination of Etoricoxib/Betamethasone versus Etoricoxib in acute gouty arthritis by comparing the level of pain in the affected joint during the 8 days of follow up. The adverse events related to the interventions will be registered during follow up. Participants will: * Be randomized into one of the 2 intervention groups (A or B) * Visit the clinic in 3 occasions (day 0, day 5 of follow up and day 8 of follow up) * In case needed the patient could take 500 mg of acetaminophen, as a rescue medication, previous authorization of de principal investigator

Conditions

• Gout Arthritis
• Gout Attack

Interventions

Type	Name	Description
DRUG	Etoricoxib + Betamethasone fixed dose	One tablet of 90 mg / 0.25 mg a day
DRUG	Etoricoxib fixed dose	One pill of 90 mg a day

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2025-03-07
• Last updated: 2025-04-03

Locations

1 site across 1 country: Mexico