| Trial ID: | L0979 |
| Source ID: | NCT01481610
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| Associated Drug: |
Lumiracoxib
|
| Title: |
Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|Arthralgia
|
| Interventions: |
DRUG: Lumiracoxib|DRUG: Diclofenac
|
| Outcome Measures: |
Primary: 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)., 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: Use of rescue medication, Proportion of patients in each group who required rescue analgesic drugs at the end of the study., Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose)|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., Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose)
|
| Sponsor/Collaborators: |
Sponsor: Hospital Central Sur de Pemex
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
28
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2012-01
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| Completion Date: |
2012-11
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| Results First Posted: |
|
| Last Update Posted: |
2013-02-13
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| Locations: |
Hospital Central Sur de Alta Especialidad PEMEX, Mexico City, DF, 14140, Mexico
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| URL: |
https://clinicaltrials.gov/show/NCT01481610
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