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Comparison of the Effects on Renal Function of Lumiracoxib and Diclofenac in Patients With Chronic Kidney Failure K/DOQI Stage III at the HCSAE PEMEX
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.
Details
| Lead sponsor | Hospital Central Sur de Pemex |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 28 |
| Start date | 2012-01 |
| Completion | 2012-11 |
Conditions
- Kidney Failure, Chronic
- Arthralgia
Interventions
- Lumiracoxib
- Diclofenac
Primary outcomes
- Change in GFR — Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient
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).
Countries
Mexico