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Interim analysis shows harma to one of the study arms.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumiracoxib group | Experimental | 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. |
|
| Diclofenac group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Molina-Calzada, M.D. | Petroleos Mexicanos - Servicios de Salud | Principal Investigator |
| Alejandro Arce-Salinas, M.D. | Petroleos Mexicanos - Servicios de Salud | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central Sur de Alta Especialidad PEMEX | Mexico City | Mexico City | 14140 | Mexico |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C473384 | lumiracoxib |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Diclofenac | Drug | 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. |
|
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) |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |