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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
One tablet of 90 mg / 0.25 mg a day
One pill of 90 mg a day
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
RECRUITINGCompare 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 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.
Time frame: 8 days
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 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.
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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.
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 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.
Time frame: 8 days