Kidney Failure, Chronic, Arthralgia
Conditions
Keywords
Kidney Failure, Chronic, Arthralgia, NSAID, Diclofenac, Lumiracoxib, Safety
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.
Interventions
DRUGLumiracoxib
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.
DRUGDiclofenac
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
Hospital Central Sur de Pemex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Outcome results
None listed