Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Silanes S.A. de C.V.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Etoricoxib + Betamethasone fixed dose
DrugOne tablet of 90 mg / 0.25 mg a day
Etoricoxib fixed dose
DrugOne pill of 90 mg a day
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Etoricoxib+BetamethasoneExperimental treatment 1 intervention
Group B: EtoricoxibActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 days2
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.
Time frame
8 daysSecondary outcomes
1
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.
Time frame
8 days2
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.
Time frame
8 days3
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.
Time frame
8 days4
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.
Time frame
8 daysOther outcomes
1
Report the number of patients who require the use of rescue medication during the clinical trial in each treatment group
The rescue medication will be acetaminophen 500 mg: - The patient that considers the need for rescue medication must call the doctor, who will be in charge of applying the VAS scale by telephone. If the doctor considers it necessary, the taking of the rescue medication will be indicated.
Time frame
8 days2
To report the percentage of therapeutic adherence at day 8 of the intervention in each treatment group.
Therapeutic adherence will be defined by the principal researcher. Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation.
Time frame
8 daysSponsors and contacts
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Source ClinicalTrials.gov