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

This study has been terminated.

(Interim analysis shows harma to one of the study arms.)

Sponsor:

Information provided by (Responsible Party):

Carlos Molina-Calzada, Hospital Central Sur de Pemex

ClinicalTrials.gov Identifier:

NCT01481610

First received: November 23, 2011

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Purpose

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	Intervention	Phase
Kidney Failure, Chronic Arthralgia	Drug: Lumiracoxib Drug: Diclofenac	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Hospital Central Sur de Pemex:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.

Enrollment:	28
Study Start Date:	January 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481610

Locations

Mexico
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

More Information

No publications provided

Responsible Party:	Carlos Molina-Calzada, Resident - Internal Medicine Department, Hospital Central Sur de Pemex
ClinicalTrials.gov Identifier:	NCT01481610 History of Changes
Other Study ID Numbers:	PEMEX-805415-00-2
Study First Received:	November 23, 2011
Last Updated:	February 11, 2013
Health Authority:	Mexico: Coordinación de Investigación en Salud

Keywords provided by Hospital Central Sur de Pemex:

Kidney Failure, Chronic
Arthralgia
NSAID

Diclofenac
Lumiracoxib
Safety

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Diclofenac
Lumiracoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013

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