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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01481610
• Other study ID #: PEMEX-805415-00-2
• Status: Terminated
• Phase: Phase 2
• First received: November 23, 2011
• Last updated: February 11, 2013
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Hospital Central Sur de Pemex
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthralgia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Hospital Central Sur de Alta Especialidad PEMEX	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central Sur de Pemex

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient	Yes
Secondary	Use of rescue medication	Proportion of patients in each group who required rescue analgesic drugs at the end of the study.	Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose)	No
Secondary	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.	Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose)	No