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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
One tablet of 90 mg / 0.25 mg a day, for 14 days
One tablet aog 90 mg a day, for 14 days
Laboratorios Silanes, S.A. de C.V.
Mexico City, Mexico City, Mexico
Change in pain during active movement of the affected joint (VAS 100 mm) at Days 3, 7, 10, and 14 vs baseline, by treatment group.
Pain intensity during active movement will be assessed using a 100-mm Visual Analog Scale (VAS) to determine whether the fixed-dose combination etoricoxib/betamethasone produces a greater reduction in pain compared with etoricoxib alone. Assessments will be obtained at baseline and at follow-up timepoints.
Time frame: Baseline and Days 3, 7, 10, and 14
Number of participants with adverse events, and comparison of adverse event frequency and intensity, by treatment group.
Safety will be assessed by comparing adverse events occurring during the study between treatment groups. Adverse events will be summarized using frequencies and percentages and classified according to seriousness/gravity, severity, and causality.
Time frame: Up to 14 days
Baseline sociodemographic, anthropometric, biochemical, and clinical characteristics, by treatment group.
Descriptive summary of participant characteristics at baseline by randomized group.
Time frame: Baseline
Daily change in maximum pain during active movement of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.
Patients will record daily VAS scores to estimate the magnitude of change from baseline in maximum pain during active movement throughout treatment.
Time frame: Daily through Day 14
Daily change in maximum pain at rest of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.
Patients will record daily VAS scores at rest to estimate the magnitude of change from baseline throughout treatment
Time frame: Daily through Day 14
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Clinical improvement using the Clinical Global Impression (CGI) scale at Days 7 and 14 vs baseline, by treatment group.
Clinical improvement will be evaluated using CGI (severity/improvement categories) at follow-up and compared with baseline by treatment group.
Time frame: Baseline, Day 7, and Day 14
Change in Patient Global Assessment of current condition at Days 7 and 14 vs baseline, by treatment group.
The Patient Global Assessment will be recorded and changes from baseline will be described by treatment group.
Time frame: Baseline, Day 7, and Day 14
Proportion of patients by category on the Patient Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Changes in the proportion of patients reporting feeling very well, well, fair, poor, or very poor will be summarized by group.
Time frame: Baseline, Day 7, and Day 14
Change in Investigator Global Assessment at Days 7 and 14 vs baseline, by treatment group.
The Investigator Global Assessment will be recorded and changes from baseline will be described by treatment group.
Time frame: Baseline, Day 7, and Day 14
Proportion of patients by category on the Investigator Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Changes in the proportion of participants classified as very well, well, fair, poor, or very poor by the investigator will be summarized by group.
Time frame: Baseline, Day 7, and Day 14