Trial | NCT01481610  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    28
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 Started
Jan 31
2012
Primary Completion
Nov 30
2012
Study Completion
Nov 30
2012
Last Update
Feb 13
2013
Estimate

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.

Lumiracoxib group Experimental

Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day) for a period of maximum 10 days, but no shorter than 7 days.

Diclofenac group Active Comparator

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.

Criteria 

Inclusion Criteria:

chronic joint pain, requiring analgesia
pre-existing chronic kidney injury, stage K/DOQI III (GFR 30 - 59 ml/min)
in a stable phase of CKD (i.e. not AKI, not hospitalized)
without contraindications for NSAID therapy
who have signed an informed consent

Exclusion Criteria:

having received any NSAID 2 weeks prior to study start
history of / actual PUD
patients with ESRD (K/DOQI IV, V or replacement therapy)
history of hypersensitivity or allergies to any of the treatments
history of / actual GI bleeding
with impaired liver function tests
using ACEI / ARB
No Results Posted