NCT01481610

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hospital Central Sur de Pemex · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Chronic
• Arthralgia

Interventions

Type	Name	Description
DRUG	Lumiracoxib	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.
DRUG	Diclofenac	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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-11-29
• Last updated: 2013-02-13

Locations

1 site across 1 country: Mexico