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Completed

NCT Number: NCT02779530

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

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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Key information

Conditions

Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unidade de Pesquisa Clínica HCRP-USP

Ribeirão Preto, São Paulo, 14048900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteers 18-65 years-old -

Exclusion criteria

Use of drugs and without clinical history of adverse effects of NSAIDS

-

Treatment and study plan

Diclofenac

Drug

50 mg po, b.i.d for 6 days

Placebo

Other

Placebo po, b.i.d. for 6 days

Primary outcomes

  1. Edema

    Time frame: after 6 days of diclofenac and placebo

    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

Secondary outcomes

  1. Blood Pressure

    Time frame: after 6 days of diclofenac and placebo

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

Sponsors and collaborators

Lead sponsor

Eduardo Barbosa Coelho

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 20, 2016
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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