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Report for Clinical Trial NCT02779530

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use

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.

NCT02779530 Drug-Related Side Effects and Adverse Reactions
MeSH:Drug-Related Side Effects and Adverse Reactions

2 Interventions

Name: Diclofenac

Description: 50 mg po, b.i.d for 6 days
Type: Drug
Group Labels: 1

Diclofenac

Name: Placebo

Description: Placebo po, b.i.d. for 6 days
Type: Other
Group Labels: 1

Placebo


Primary Outcomes

Description: 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

Measure: Edema

Time: after 6 days of diclofenac and placebo

Secondary Outcomes

Description: Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM)

Measure: Blood Pressure

Time: after 6 days of diclofenac and placebo

Purpose: Screening

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 V433M

Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). --- V433M ---



HPO Nodes