NCT02779530

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

May 17, 2016

Last Update Submit

May 17, 2016

Conditions

Drug-Related Side Effects and Adverse Reactions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Blood Pressure

    after 6 days of diclofenac and placebo

Study Arms (2)

Diclofenac

EXPERIMENTAL
Drug: Diclofenac

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

DiclofenacDRUG

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

Diclofenac
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidade de Pesquisa Clínica HCRP-USP

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Nephrology Division - Internal Medicine Dept. Ribeirão Preto Medical School University of São Paulo

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 20, 2016

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 20, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)