The purpose of this study is to determine whether the use of lumiracoxib in this particular population is associated with a decrease in glomerular filtration rate (GFR) compared to diclofenac; and to compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day), for a period no longer than 10 days, but no shorter than 7 days.
Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days.
Hospital Central Sur de Alta Especialidad PEMEX
Mexico City, Mexico City, Mexico
Change in GFR
Magnitude of change in GFR (ml / min) as measured by creatinine clearance in urine over 24 hours, considering the initial and final value at the end of the study. Creatinine clearance will be measured twice: initially, prior to the first dose of medication (baseline), and again at the end of treatment (ie. 10 days after starting dose).
Time frame: Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient
Use of rescue medication
Proportion of patients in each group who required rescue analgesic drugs at the end of the study.
Time frame: Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose)
Subjective improvement in pain
Change in the subjective perception of pain, assessed with help of a validated Visual Analog Scale both prior to the start of treatment and again at the end of treatment.
Time frame: Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose)
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