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

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.

Timeline

Start

2025-05-14

Primary completion

2025-08-20

Completion

2025-11-19

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background (EMA), E.M.A., Guideline on clinical development of fixed combination medicinal products. 2017.
• 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Han, S., Clinical pharmacology review for primary health care providers: II. Steroids. Transl Clin Pharmacol., 2015.
• 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.
• 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.
• Background 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.
• Background 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.
• Background Green S, Buchbinder R, Glazier R, Forbes A. Interventions for shoulder pain. Cochrane Database Syst Rev. 2000;(2):CD001156. doi: 10.1002/14651858.CD001156.

Drugs

Indications