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

NCT07328022 | Completed Phase 3

• 1 other identifier: SIL-30953-III-24(1)
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bursitis; Tendinitis; Synovitis

Keywords

Bursitis; Tendinitis; Synovitis; Etoricoxib; Betamethasone; Acute Episode

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 14 days

Secondary Outcomes (8)

• Baseline sociodemographic, anthropometric, biochemical, and clinical characteristics, by treatment group.

  Baseline

• Daily change in maximum pain during active movement of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.

  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.

  Daily through Day 14

• Clinical improvement using the Clinical Global Impression (CGI) scale at Days 7 and 14 vs baseline, by treatment group.

  Baseline, Day 7, and Day 14

• Change in Patient Global Assessment of current condition at Days 7 and 14 vs baseline, by treatment group.

  Baseline, Day 7, and Day 14

Study Arms (2)

Etoricoxib + Betamethasone

EXPERIMENTAL

Administered orally, 1 tablet a day for 14 days.

Drug: Fixed Dose Etoricoxib + Betamethasone

Etoricoxib

ACTIVE COMPARATOR

Administered orally, 1 tablet a day for 14 days.

Drug: Monotherapy Etoricoxib

Interventions

Fixed Dose Etoricoxib + Betamethasone DRUG

One tablet of 90 mg / 0.25 mg a day, for 14 days

Etoricoxib + Betamethasone

Monotherapy Etoricoxib DRUG

One tablet aog 90 mg a day, for 14 days

Etoricoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• In the opinion of the Principal Investigator or treating physician, the participant is an appropriate candidate for treatment with the investigational product.

You may not qualify if:

• 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 disease or condition that, in the investigator's opinion, could pose a risk to the patient or confound the efficacy and safety evaluation of the investigational product, such as significant degenerative disease or an infectious process in the joints of interest.
• Pregnant or breastfeeding patients.
• Contraindication to the study medications.
• History of allergic reaction to NSAIDs (non-steroidal anti-inflammatory drugs), paracetamol (acetaminophen), or known hypersensitivity to the study medications.
• Significant history of gastrointestinal disorders (e.g., gastric ulcer, Crohn's disease, ulcerative colitis, gastrointestinal bleeding, etc.).
• History of congestive heart failure (NYHA Class II-IV), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization procedures or angioplasty).
• Treatment with corticosteroids within 1 month prior to study start.
• Treatment with NSAIDs within 48 hours prior to study start, except for cardioprotective-dose aspirin.
• Tendinitis or bursitis secondary to a systemic inflammatory disease, or synovitis secondary to hemophilia.
• History of harmful alcohol and/or drug use causing adverse health and social effects.
• Clinical suspicion of joint infection or another joint disease other than tendinitis, bursitis, or synovitis.
• History of chronic hepatic impairment (Child-Pugh A, B, and/or C).

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorios Silanes, S.A. de C.V.

Mexico City, Mexico City, 11000, Mexico

Location

Related Publications (19)

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  BACKGROUND

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MeSH Terms

Conditions

Bursitis; Tendinopathy; Synovitis

Interventions

Etoricoxib; Betamethasone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marco Antonio Cordova Martinez, MD

  Unidad de Medicina Especializada SMA SC

  PRINCIPAL INVESTIGATOR

• Pedro Abraham Garza Alvarez, MD

  IECSI Clinical Research

  PRINCIPAL INVESTIGATOR

• Juan Luis Torres Mendez, MD

  Clinical Research Institute S.C.

  PRINCIPAL INVESTIGATOR

• Yazmin Adriana Guerra Lopez, MD

  Centro de Investigación Clínica de México S. de R.L. de C.V

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 8, 2026
• Study Start: May 14, 2025
• Primary Completion: August 20, 2025
• Study Completion: November 19, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)