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

Official title

Efficacy and Safety Study for the Combination of Etoricoxib / Betamethasone Compared to Etoricoxib for the Treatment of Patients Diagnosed With Acute Gout Arthritis

Overview

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

Detailed description

Researchers will compare the fixed-dose combination of Etoricoxib/Betamethasone versus Etoricoxib in acute gouty arthritis by comparing the level of pain in the affected joint during the 8 days of follow up. The adverse events related to the interventions will be registered during follow up.

Participants will:

* Be randomized into one of the 2 intervention groups (A or B) * Visit the clinic in 3 occasions (day 0, day 5 of follow up and day 8 of follow up) * In case needed the patient could take 500 mg of acetaminophen, as a rescue medication, previous authorization of de principal investigator

Interventions

• Drug Etoricoxib + Betamethasone fixed dose
  One tablet of 90 mg / 0.25 mg a day
• Drug Etoricoxib fixed dose
  One pill of 90 mg a day

Primary outcome measures

• 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. [Time frame: 8 days]
• Number of participants with treatment-related adverse events through the patient's diary record. [Time frame: 8 days]

Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 8 days]

Eligibility criteria

Inclusion criteria

• 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).
• Acute episode characterized by severe pain, inflammation, edema, and erythema in the affected joint (≤ 48 hours before study inclusion).
• In the opinion of the Principal Investigator or treating physician, the patient is eligible for treatment with the investigational product and may benefit clinically

Exclusion criteria

• 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.
• History of chronic liver failure (Child-Pugh A, B, and/or C), as reported in medical history or patient interview.
• History of chronic renal failure (glomerular filtration rate <30 ml/min/1.73 m²), as reported in medical history or patient interview.
• Significant history of known coagulation disorders (e.g., Von Willebrand disease, hemophilia, vitamin K deficiency, etc.) or use of anticoagulants, as reported in medical history or patient interview.
• Oncology patients (except for basal cell skin cancer) or patients with severe diseases that, in the investigator's opinion, have a severe prognosis or a life expectancy of less than one year, as well as patients with mental illnesses.
• Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, shortness of breath) and/or contact within the last 14 days with a suspected or confirmed COVID-19 case.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Mexico · 1 center

• Laboratorio Silanes, S.A. de C.V. — Mexico City

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06863701 · SIL- 30953 - III - 23 (1)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗