Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis

NCT06863701 | Recruiting Phase 3 DMC

• 1 other identifier: SIL- 30953 - III - 23 (1)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Betamethasone Versus Etoricoxib in Patients With Acute Gouty Arthritis

Conditions

Gout Arthritis; Gout Attack

Keywords

Gout Arthritis; Gout Attack; Etoricoxib; Betamethasone

Outcome Measures

Primary Outcomes (2)

• Compare the degree of pain in the affected joint (using the Likert pain scale) on days 2, 5, and 8, according to their baseline measurement in each treatment group.

  A Likert pain scale is a rating scale used to measure opinions, attitudes, or behaviors. It consists of a statement or a question, followed by a series of four answer statements. The pain should be assessed by the principal investigator or designated physician by asking the patient about the joint experiencing the MOST PAIN at the time of the baseline evaluation and during follow-up.

  8 days

• Number of participants with treatment-related adverse events through the patient's diary record.

  To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.

  8 days

Secondary Outcomes (4)

• Compare the degree of inflammation (edema) in the affected joint (using the Likert edema scale) on days 2, 5, and 8 according to the baseline measurement for each treatment group.

  8 days

• Compare the degree of inflammation (erythema) in the affected joint (using the Likert edema scale) on days 2, 5, and 8 according to the baseline measurement for each treatment group.

  8 days

• Describe the patient's subjective global assessment of the treatment received at the end of the 8-day follow-up period, by treatment group.

  8 days

• Describe the investigator's subjective global assessment of the treatment received by the patient at the end of the 8-day follow-up period, by treatment group.

  8 days

Other Outcomes (2)

• Report the number of patients who require the use of rescue medication during the clinical trial in each treatment group

  8 days

• To report the percentage of therapeutic adherence at day 8 of the intervention in each treatment group.

  8 days

Study Arms (2)

Etoricoxib+Betamethasone

EXPERIMENTAL

Administered orally, 1 tablet a day for 8 days.

Drug: Etoricoxib + Betamethasone fixed dose

Etoricoxib

ACTIVE COMPARATOR

Administered orally, 1 pill a day for 8 days.

Drug: Etoricoxib fixed dose

Interventions

Etoricoxib + Betamethasone fixed dose DRUG

One tablet of 90 mg / 0.25 mg a day

Also known as: Etori + Beta

Etoricoxib+Betamethasone

Etoricoxib fixed dose DRUG

One pill of 90 mg a day

Also known as: Etori

Etoricoxib

Eligibility Criteria

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

You may qualify if:

• Willing to participate in the study and provide written informed consent.
• Women of childbearing potential and sexually active must use an acceptable contraceptive method (barrier and/or hormonal) as determined by the investigator.
• History of hyperuricemia diagnosis (uric acid \> 7 mg/dL) reported in medical history or patient interview.
• Clinical diagnosis of acute gouty arthritis with a score of at least 4 based on the following criteria: Male (2 points), history of a similar episode (2 points), symptom onset within the last 24 hours (0.5 points), joint redness (1 point), involvement of the first metatarsophalangeal joint (2.5 points), and hypertension or at least one cardiovascular disease (1.5 points).
• In the opinion of the Principal Investigator or treating physician, the patient is eligible for treatment with the investigational product and may benefit clinically

You may not qualify if:

• Patients participating in another clinical study involving an investigational treatment or participation in one within the two weeks prior to study initiation.
• Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.).
• In the investigator's judgment, any condition that affects prognosis and prevents outpatient management, which must be assessed by the principal investigator to determine the patient's eligibility.
• History of severe, progressive, or unstable advanced disease of any kind that may interfere with efficacy and safety evaluations or put the patient at risk.
• Pregnant or breastfeeding patients.
• The study medication is contraindicated for medical reasons.
• History of intolerance or allergic reaction to NSAIDs (nonsteroidal anti-inflammatory drugs), paracetamol, or known hypersensitivity to any component of the formulation.
• Significant history of gastrointestinal disorders (e.g., gastric ulcer, Crohn's disease, ulcerative colitis, gastrointestinal bleeding, etc.).
• History of congestive heart failure (NYHA classification II-IV), established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization or angioplasty).
• Treatment with systemic corticosteroids for the management of acute gouty arthritis within two weeks before study initiation.
• Treatment with NSAIDs within 48 hours prior to study initiation, except for aspirin at cardioprotective doses.
• History of treatment failure with selective COX-2 inhibitors, as reported in medical history or patient interview.
• Presence of acute polyarticular gout affecting more than four joints.
• History of alcohol or drug abuse within the past year.
• Clinical suspicion of joint infection or another joint disease different from acute gouty arthritis.

Sponsors & Collaborators

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

Study Sites (1)

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

Mexico City, 11000, Mexico

RECRUITING

Related Publications (13)

• Li M, Yu C, Zeng X. Comparative efficacy of traditional non-selective NSAIDs and selective cyclo-oxygenase-2 inhibitors in patients with acute gout: a systematic review and meta-analysis. BMJ Open. 2020 Sep 10;10(9):e036748. doi: 10.1136/bmjopen-2019-036748.

  PMID: 32912981 BACKGROUND

• van Durme CM, Wechalekar MD, Landewe RB, Pardo Pardo J, Cyril S, van der Heijde D, Buchbinder R. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2021 Dec 9;12(12):CD010120. doi: 10.1002/14651858.CD010120.pub3.

  PMID: 34882311 BACKGROUND

• Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.

  PMID: 34760748 BACKGROUND

• Man CY, Cheung IT, Cameron PA, Rainer TH. Comparison of oral prednisolone/paracetamol and oral indomethacin/paracetamol combination therapy in the treatment of acute goutlike arthritis: a double-blind, randomized, controlled trial. Ann Emerg Med. 2007 May;49(5):670-7. doi: 10.1016/j.annemergmed.2006.11.014. Epub 2007 Feb 5.

  PMID: 17276548 BACKGROUND

• Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van Weel C. Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial. Lancet. 2008 May 31;371(9627):1854-60. doi: 10.1016/S0140-6736(08)60799-0.

  PMID: 18514729 BACKGROUND

• Rainer TH, Cheng CH, Janssens HJ, Man CY, Tam LS, Choi YF, Yau WH, Lee KH, Graham CA. Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):464-71. doi: 10.7326/M14-2070. Epub 2016 Feb 23.

  PMID: 26903390 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.

  PMID: 23506281 BACKGROUND

• Clarke R, Derry S, Moore RA. Single dose oral etoricoxib for acute postoperative pain in adults. Cochrane Database Syst Rev. 2014 May 8;2014(5):CD004309. doi: 10.1002/14651858.CD004309.pub4.

  PMID: 24809657 BACKGROUND

• Xu L, Liu S, Guan M, Xue Y. Comparison of Prednisolone, Etoricoxib, and Indomethacin in Treatment of Acute Gouty Arthritis: An Open-Label, Randomized, Controlled Trial. Med Sci Monit. 2016 Mar 11;22:810-7. doi: 10.12659/msm.895749.

  PMID: 26965791 BACKGROUND

• Neilson J, Bonnon A, Dickson A, Roddy E; Guideline Committee. Gout: diagnosis and management-summary of NICE guidance. BMJ. 2022 Aug 30;378:o1754. doi: 10.1136/bmj.o1754. No abstract available.

  PMID: 36041743 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.

  PMID: 33910619 BACKGROUND

• Pelaez-Ballestas I, Sanin LH, Moreno-Montoya J, Alvarez-Nemegyei J, Burgos-Vargas R, Garza-Elizondo M, Rodriguez-Amado J, Goycochea-Robles MV, Madariaga M, Zamudio J, Santana N, Cardiel MH; Grupo de Estudio Epidemiologico de Enfermedades Musculo Articulares (GEEMA). Epidemiology of the rheumatic diseases in Mexico. A study of 5 regions based on the COPCORD methodology. J Rheumatol Suppl. 2011 Jan;86:3-8. doi: 10.3899/jrheum.100951.

  PMID: 21196592 BACKGROUND

• FitzGerald JD, Dalbeth N, Mikuls T, Brignardello-Petersen R, Guyatt G, Abeles AM, Gelber AC, Harrold LR, Khanna D, King C, Levy G, Libbey C, Mount D, Pillinger MH, Rosenthal A, Singh JA, Sims JE, Smith BJ, Wenger NS, Bae SS, Danve A, Khanna PP, Kim SC, Lenert A, Poon S, Qasim A, Sehra ST, Sharma TSK, Toprover M, Turgunbaev M, Zeng L, Zhang MA, Turner AS, Neogi T. 2020 American College of Rheumatology Guideline for the Management of Gout. Arthritis Rheumatol. 2020 Jun;72(6):879-895. doi: 10.1002/art.41247. Epub 2020 May 11.

  PMID: 32390306 BACKGROUND

MeSH Terms

Conditions

Arthritis, Gouty

Interventions

Etoricoxib; Betamethasone

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

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

• Rafael Lanuza-Ramirez, MD

  Consultorio Médico "Dr. Rodrigo Suárez Otero"

  PRINCIPAL INVESTIGATOR

• Rodrigo Suarez-Otero, MD

  SMIQ, S. De. R.L. de C.V. (Grupo Cien y ético de Querétaro)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge A Gonzalez, PhD

CONTACT

5254883785; jogonzalez@silanes.com.mx

Yulia Romero-Antonio, B.S.

CONTACT

5254883785; yromero@silanes.com.mx

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)