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

Sponsor

Hospital Central Sur de Pemex (Other)

Overall Status

Terminated

CT.gov ID

NCT01481610

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Arthralgia	Drug: Lumiracoxib Drug: Diclofenac	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lumiracoxib group 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.	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.
Active Comparator: Diclofenac group 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.	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.

Arm

Intervention/Treatment

Experimental: Lumiracoxib group

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.

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.

Active Comparator: Diclofenac group

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.

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.

Outcome Measures

Primary Outcome Measures

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).

Secondary Outcome Measures

Use of rescue medication [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Central Sur de Alta Especialidad PEMEX	Mexico City	DF	Mexico	14140

Sponsors and Collaborators

Hospital Central Sur de Pemex

Investigators

Principal Investigator: Carlos Molina-Calzada, M.D., Petroleos Mexicanos - Servicios de Salud
Study Director: Alejandro Arce-Salinas, M.D., Petroleos Mexicanos - Servicios de Salud