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Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | 50 mg po, b.i.d for 6 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Edema | Presence of edema, measured by the estimative of total body water (deuterium oxide dilution technique). The measurements will be done in the end of 6 days of use of placebo and diclofenac, and the delta between diclofenac and placebo will be used as endpoint | after 6 days of diclofenac and placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM) | after 6 days of diclofenac and placebo |
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Inclusion Criteria: Healthy volunteers 18-65 years-old -
Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Pesquisa ClÃnica HCRP-USP | Ribeirão Preto | São Paulo | 14048900 | Brazil |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Other |
Placebo po, b.i.d. for 6 days |
|