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

Primary Purpose

Kidney Failure, Chronic, Arthralgia

Status
Terminated
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Lumiracoxib
Diclofenac
Sponsored by
Hospital Central Sur de Pemex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Kidney Failure, Chronic, Arthralgia, NSAID, Diclofenac, Lumiracoxib, Safety

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Central Sur de Alta Especialidad PEMEX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumiracoxib group

Diclofenac group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Use of rescue medication
Proportion of patients in each group who required rescue analgesic drugs at the end of the study.
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.

Full Information

First Posted
November 23, 2011
Last Updated
February 11, 2013
Sponsor
Hospital Central Sur de Pemex
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1. Study Identification

Unique Protocol Identification Number
NCT01481610
Brief Title
Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis shows harma to one of the study arms.
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Central Sur de Pemex

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Arthralgia
Keywords
Kidney Failure, Chronic, Arthralgia, NSAID, Diclofenac, Lumiracoxib, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumiracoxib group
Arm Type
Experimental
Arm Description
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.
Arm Title
Diclofenac group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lumiracoxib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in GFR
Description
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).
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
Secondary Outcome Measure Information:
Title
Use of rescue medication
Description
Proportion of patients in each group who required rescue analgesic drugs at the end of the study.
Time Frame
Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose)
Title
Subjective improvement in pain
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Molina-Calzada, M.D.
Organizational Affiliation
Petroleos Mexicanos - Servicios de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alejandro Arce-Salinas, M.D.
Organizational Affiliation
Petroleos Mexicanos - Servicios de Salud
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Central Sur de Alta Especialidad PEMEX
City
Mexico City
State/Province
DF
ZIP/Postal Code
14140
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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