NCT07328022

Efficacy and Safety of Etoricoxib/Betamethasone Combination in Acute Bursitis, Tendinitis and Synovitis

Efficacy and Safety Study of the Etoricoxib/Betamethasone Combination Compared With Etoricoxib for the Treatment of Patients Diagnosed With an Acute Episode of Bursitis, Tendinitis, or Synovitis of the Shoulder, Elbow, Knee, or Ankle

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III, multicenter, prospective, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of a fixed-dose combination of etoricoxib/betamethasone compared with etoricoxib alone in patients with an acute episode of bursitis, tendinitis, or synovitis affecting the shoulder, elbow, knee, or ankle.

Detailed description

This is a Phase III, multicenter, prospective, randomized, double-blind, parallel-group study to compare the efficacy and safety of a fixed-dose combination of etoricoxib/betamethasone versus etoricoxib alone in patients with an acute episode of bursitis, tendinitis, or synovitis of the shoulder, elbow, knee, or ankle. Eligible participants will be randomized to receive either etoricoxib/betamethasone 90 mg/0.25 mg once daily for 14 days (Group A) or etoricoxib 90 mg once daily for 14 days (Group B). The study includes three visits (Day 1 baseline, Day 7 ± 2, Day 14 ± 2) and two follow-up calls (Day 3 ± 2 and Day 10 ± 2); investigators will collect medical history, perform physical examinations focused on the affected region, and review laboratory and diagnostic assessments as applicable. Pain intensity in the affected joint will be assessed using a Visual Analog Scale (VAS) during active movement and at rest at each visit/call, and daily by patients in a trained Patient Diary completed in the afternoon at the same time each day. Outcomes include changes from baseline in maximum pain (movement and rest) over 14 days, clinical improvement at Days 7 and 14 using the Clinical Global Impression scale, patient and investigator global assessments, and safety based on adverse events summarized by treatment group; rescue medication use (paracetamol 500 mg) and treatment adherence will also be evaluated.

Conditions

• Bursitis
• Tendinitis
• Synovitis

Interventions

Type	Name	Description
DRUG	Fixed Dose Etoricoxib + Betamethasone	One tablet of 90 mg / 0.25 mg a day, for 14 days
DRUG	Monotherapy Etoricoxib	One tablet aog 90 mg a day, for 14 days

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-08-20
• Completion: 2025-11-19
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Mexico