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

NCT ID: NCT07328022

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2025-11-19

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Etoricoxib + Betamethasone

Administered orally, 1 tablet a day for 14 days.

Group Type: EXPERIMENTAL

Fixed Dose Etoricoxib + Betamethasone

Intervention Type: DRUG

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

Etoricoxib

Administered orally, 1 tablet a day for 14 days.

Group Type: ACTIVE_COMPARATOR

Monotherapy Etoricoxib

Intervention Type: DRUG

One tablet aog 90 mg a day, for 14 days

Interventions

Fixed Dose Etoricoxib + Betamethasone

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

Intervention Type: DRUG

Monotherapy Etoricoxib

One tablet aog 90 mg a day, for 14 days

Intervention Type: DRUG

Eligibility Criteria

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 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.
• Fever: axillary temperature > 37.5°C within 2 days prior to or at the time of study inclusion.-
• 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).
• History of acute renal failure or chronic kidney disease (glomerular filtration rate < 30 mL/min/1.73 m²).
• Significant history of known coagulation disorders (e.g., von Willebrand disease, hemophilia, vitamin K deficiency, etc.) or use of anticoagulants.
• Oncology patients (except basal cell skin cancer or patients with cancer in remission) or patients with severe diseases that, in the investigator's opinion, have a poor prognosis or a life expectancy of less than 1 year, as well as mental illnesses.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Silanes S.A. de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Antonio Cordova Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Medicina Especializada SMA SC

Pedro Abraham Garza Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

IECSI Clinical Research

Juan Luis Torres Mendez, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Institute S.C.

Yazmin Adriana Guerra Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Mexico City, Mexico City, Mexico

Countries

Mexico

References

Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.

Reference Type: BACKGROUND

PMID: 9835471 (View on PubMed)

Bertin P, Behier JM, Noel E, Leroux JL. Celecoxib is as efficacious as naproxen in the management of acute shoulder pain. J Int Med Res. 2003 Mar-Apr;31(2):102-12. doi: 10.1177/147323000303100206.

Reference Type: BACKGROUND

PMID: 12760313 (View on PubMed)

Pincus T, Swearingen CJ, Luta G, Sokka T. Efficacy of prednisone 1-4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial. Ann Rheum Dis. 2009 Nov;68(11):1715-20. doi: 10.1136/ard.2008.095539. Epub 2008 Dec 15.

Reference Type: BACKGROUND

PMID: 19074913 (View on PubMed)

Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.

Reference Type: BACKGROUND

PMID: 15370723 (View on PubMed)

Matsumoto AK, Melian A, Mandel DR, McIlwain HH, Borenstein D, Zhao PL, Lines CR, Gertz BJ, Curtis S; Etoricoxib Rheumatoid Arthritis Study Group. A randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis. J Rheumatol. 2002 Aug;29(8):1623-30.

Reference Type: BACKGROUND

PMID: 12180720 (View on PubMed)

Pisaniello HL, Fisher MC, Farquhar H, Vargas-Santos AB, Hill CL, Stamp LK, Gaffo AL. Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review. Arthritis Res Ther. 2021 Apr 28;23(1):130. doi: 10.1186/s13075-021-02416-y.

Reference Type: BACKGROUND

PMID: 33910619 (View on PubMed)

(EMA), E.M.A., Guideline on clinical development of fixed combination medicinal products. 2017.

Reference Type: BACKGROUND

Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19.

Reference Type: BACKGROUND

PMID: 29055500 (View on PubMed)

la Torre LF, Franco-Gonzalez DL, Brennan-Bourdon LM, Molina-Frechero N, Alonso-Castro AJ, Isiordia-Espinoza MA. Analgesic Efficacy of Etoricoxib following Third Molar Surgery: A Meta-analysis. Behav Neurol. 2021 Sep 8;2021:9536054. doi: 10.1155/2021/9536054. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34539935 (View on PubMed)

Watson DJ, Bolognese JA, Yu C, Krupa D, Curtis S. Use of gastroprotective agents and discontinuations due to dyspepsia with the selective cyclooxygenase-2 inhibitor etoricoxib compared with non-selective NSAIDs. Curr Med Res Opin. 2004 Dec;20(12):1899-908. doi: 10.1185/030079904X12681.

Reference Type: BACKGROUND

PMID: 15701208 (View on PubMed)

Petri M, Hufman SL, Waser G, Cui H, Snabes MC, Verburg KM. Celecoxib effectively treats patients with acute shoulder tendinitis/bursitis. J Rheumatol. 2004 Aug;31(8):1614-20.

Reference Type: BACKGROUND

PMID: 15290743 (View on PubMed)

Maquirriain J, Kokalj A. Management of acute Achilles tendinopathy: effect of etoricoxib on pain control and leg stiffness. Georgian Med News. 2013 Sep;(222):36-43.

Reference Type: BACKGROUND

PMID: 24099813 (View on PubMed)

Becker DE. Basic and clinical pharmacology of glucocorticosteroids. Anesth Prog. 2013 Spring;60(1):25-31; quiz 32. doi: 10.2344/0003-3006-60.1.25.

Reference Type: BACKGROUND

PMID: 23506281 (View on PubMed)

Han, S., Clinical pharmacology review for primary health care providers: II. Steroids. Transl Clin Pharmacol., 2015.

Reference Type: BACKGROUND

Gómez Valdés, A., Y. Mendoza Cabrera, and L. Escalante Cambeaux, Sinovitis de rodilla, su tratamiento en el área terapéutica de la Facultad de Cultura Física "Nancy Uranga Romagoza". Podium. Revista de Ciencia y Tecnología en la Cultura Física, 2018. 13: p. 274-286.

Reference Type: BACKGROUND

Tak PP, Breedveld FC. Current perspectives on synovitis. Arthritis Res. 1999;1(1):11-6. doi: 10.1186/ar4. Epub 1999 Oct 26. No abstract available.

Reference Type: BACKGROUND

PMID: 11094407 (View on PubMed)

Miranda H, Viikari-Juntura E, Martikainen R, Riihimaki H. A prospective study on knee pain and its risk factors. Osteoarthritis Cartilage. 2002 Aug;10(8):623-30. doi: 10.1053/joca.2002.0796.

Reference Type: BACKGROUND

PMID: 12479384 (View on PubMed)

van der Windt DA, Koes BW, Boeke AJ, Deville W, De Jong BA, Bouter LM. Shoulder disorders in general practice: prognostic indicators of outcome. Br J Gen Pract. 1996 Sep;46(410):519-23.

Reference Type: BACKGROUND

PMID: 8917870 (View on PubMed)

Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

Reference Type: BACKGROUND

PMID: 12804509 (View on PubMed)

Other Identifiers

SIL-30953-III-24(1)

Identifier Type: -

Identifier Source: org_study_id