Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
NCT01481610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2013-02-13
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.
Conditions
- Kidney Failure, Chronic
- Arthralgia
Interventions
- 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.
Sponsors & Collaborators
-
Hospital Central Sur de Pemex
lead OTHER
Principal Investigators
-
Carlos Molina-Calzada, M.D. · Petroleos Mexicanos - Servicios de Salud
-
Alejandro Arce-Salinas, M.D. · Petroleos Mexicanos - Servicios de Salud
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Mexico
Study Locations
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