Efficacy and Safety of Etoricoxib/Betamethasone Combination in Acute Bursitis, Tendinitis and Syn… (NCT07328022) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Etoricoxib/Betamethasone Combination in Acute Bursitis, Tendinitis and Synovitis
Mexico89 participantsStarted 2025-05-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients willing and able to participate in the study and provide written informed consent.
* Male or female.
* Age ≥ 18 years at study entry.
* Women of childbearing potential who use an acceptable contraceptive method (barrier, oral hormonal, injectable, subdermal), or women who are naturally postmenopausal or surgically sterile.
* Clinical diagnosis of an acute episode of tendinitis, bursitis, or synovitis of the shoulder, elbow, knee, or ankle, with onset within 7 days prior to the first dose of study medication.
* A score ≥ 40 mm on a 100-mm Visual Analog Scale (VAS) for maximum pain intensity during active movement, as reported by the patient at the time of study inclusion.
* In the opinion of the Principal Investigator or treating physician, the participant is an appropriate candidate for treatment with the investigational product.
Exclusion Criteria:
* Participation in another clinical study involving an investigational treatment, or participation in such a study within 4 weeks prior to study start.
* Patients whose participation could be influenced (e.g., employment relationship with the study site or sponsor, vulnerable populations, etc.).
* In the investigator's medical judgment, any disease that affects prognosis and prevents outpatient management, including but not limited to: terminal cancer, renal, cardiac, respiratory, or hepatic failure, mental illness, or scheduled surgical procedures or hospitalizations.
* History or presence of any…
What they're measuring
1
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.
Timeframe: Baseline and Days 3, 7, 10, and 14
2
Number of participants with adverse events, and comparison of adverse event frequency and intensity, by treatment group.