CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs

Eduardo Barbosa Coelho

Status and phase: Completed; Phase 4

Conditions: Drug-Related Side Effects and Adverse Reactions

Treatments: Drug: Diclofenac; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02779530

U1111-1131-8461

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Healthy volunteers 18-65 years-old -

Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Diclofenac

Experimental group

Treatment:

Drug: Diclofenac

Placebo

Placebo Comparator group

Treatment:

Other: Placebo