Gout ArthritisPhase 3NCT06863701
Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis
A Phase 3 study testing Etoricoxib + Betamethasone fixed dose and Etoricoxib fixed dose in people with Gout Arthritis and Gout Attack, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Arthritis, Gout Attack
- What is being tested?
- Etoricoxib + Betamethasone fixed dose and Etoricoxib fixed dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteMexico
- Study dates
- 27 Jan 2025to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000
Jorge A Gonzalez, PhD, 5254883785 ext. 3761, jogonzalez@silanes.com.mx
Yulia Romero-Antonio, B.S., 5554883700, yromero@silanes.com.mx
About this study
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
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
Read the 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
- Conditions
- Gout Arthritis, Gout Attack
- Being tested
- Etoricoxib + Betamethasone fixed dose, Etoricoxib fixed dose
- Keywords
- Gout Arthritis, Gout Attack, Etoricoxib, Betamethasone
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoricoxib + Betamethasone fixed doseDrug
Also called Etori + Beta
One tablet of 90 mg / 0.25 mg a day
Etoricoxib fixed doseDrug
Also called Etori
One pill of 90 mg a day
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib+Betamethasone | Experimental | Administered orally, 1 tablet a day for 8 days. Receives: Drug: Etoricoxib + Betamethasone fixed dose |
| Etoricoxib | Active comparator | Administered orally, 1 pill a day for 8 days. Receives: Drug: Etoricoxib fixed dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
A Likert edema 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 three answer statements. The evaluation must be conducted by the Site Principal Investigator or designated physician on the most affected joint at baseline and during follow-up.
Measured: 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.
A Likert erythema 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 three answer statements. The evaluation must be conducted by the Site Principal Investigator or designated physician on the most affected joint at baseline and during follow-up.
Measured: 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.
The Investigator must ask the patient the following question:
"How would you rate the study medication you received for acute gouty arthritis?" at day 8 of follow-up. The assessment would be through a likert scale. The likert scales 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.
Measured: 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.
How would the investigator rate the treatment with the study medication the patient received for acute gouty arthritis?. The question would be assessed through a likert scale. The likert scales 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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start27 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gout ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafael Lanuza-Ramirez, MD, Principal investigator, Consultorio Médico "Dr. Rodrigo Suárez Otero"Rodrigo Suarez-Otero, MD, Principal investigator, SMIQ, S. De. R.L. de C.V. (Grupo Cien y ético de Querétaro)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863701
- Sponsor's protocol ID
- SIL- 30953 - III - 23 (1)
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32912981van 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.
PubMed 34882311Shukla 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.
PubMed 34760748Man 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.
PubMed 17276548Janssens 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.
PubMed 18514729Rainer 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.
PubMed 26903390Becker 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.
PubMed 23506281Clarke 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.
PubMed 24809657Xu 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.
PubMed 26965791Neilson 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.
PubMed 36041743Pisaniello 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.
PubMed 33910619Pelaez-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.
PubMed 21196592FitzGerald 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.
PubMed 32390306
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06863701
- Acronym / sponsor ID
- SIL- 30953 - III - 23 (1)
- Conditions
- Gout Arthritis, Gout Attack
- Keywords
- Gout Arthritis, Gout Attack, Etoricoxib, Betamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib+Betamethasone | Experimental | Drug: Etoricoxib + Betamethasone fixed doseAdministered orally, 1 tablet a day for 8 days. |
| Etoricoxib | Active comparator | Drug: Etoricoxib fixed doseAdministered orally, 1 pill a day for 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoricoxib + Betamethasone fixed doseAlso: Etori + BetaOne tablet of 90 mg / 0.25 mg a day | Drug | Etoricoxib+Betamethasone |
| Etoricoxib fixed doseAlso: EtoriOne pill of 90 mg a day | Drug | Etoricoxib |
Primary outcome
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
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.
Number of participants with treatment-related adverse events through the patient's diary record.
Time frame: 8 days
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 32912981Li 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.
- Background: PubMed 34882311van 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.
- Background: PubMed 34760748Shukla 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.
- Background: PubMed 17276548Man 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.
- Background: PubMed 18514729Janssens 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.
- Background: PubMed 26903390Rainer 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.
- Background: PubMed 23506281Becker 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: PubMed 24809657Clarke 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.
- Background: PubMed 26965791Xu 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.
- Background: PubMed 36041743Neilson 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.
- Background: PubMed 33910619Pisaniello 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: PubMed 21196592Pelaez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Lanuza-Ramirez, MD principal investigator
Consultorio Médico "Dr. Rodrigo Suárez Otero"
Rodrigo Suarez-Otero, MD principal investigator
SMIQ, S. De. R.L. de C.V. (Grupo Cien y ético de Querétaro)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoricoxib + Betamethasone fixed dose and Etoricoxib fixed dose in people with Gout Arthritis and Gout Attack, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge A Gonzalez, PhD (5254883785 ext. 3761, jogonzalez@silanes.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863701, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.