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

NCT ID: NCT02779530

Last Updated: 2016-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Drug-Related Side Effects and Adverse Reactions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac

Group Type EXPERIMENTAL

Diclofenac

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Diclofenac

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eduardo Barbosa Coelho

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Barbosa Coelho

Associate Professor Nephrology Division - Internal Medicine Dept. Ribeirão Preto Medical School University of São Paulo

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Unidade de Pesquisa Clínica HCRP-USP

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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U1111-1131-8461

Identifier Type: -

Identifier Source: org_study_id

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