Clinical Trial: Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Hospital Central Sur de Pemex

Current Primary Outcome: Change in GFR [ 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 ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Use of rescue medication [ Time Frame: Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose) ]
    Proportion of patients in each group who required rescue analgesic drugs at the end of the study.
  • Subjective improvement in pain [ 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) ]
    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.


Original Secondary Outcome: Same as current

Information By: Hospital Central Sur de Pemex

Dates:
Date Received: November 23, 2011
Date Started: January 2012
Date Completion:
Last Updated: February 11, 2013
Last Verified: February 2013