Back to resultsCYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
Primary Purpose
Drug-Related Side Effects and Adverse Reactions
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Diclofenac
Placebo
Sponsored by
About this trial
This is an interventional screening trial for Drug-Related Side Effects and Adverse Reactions
Eligibility Criteria
Inclusion Criteria: Healthy volunteers 18-65 years-old -
Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS
-
Sites / Locations
- Unidade de Pesquisa Clínica HCRP-USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diclofenac
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Blood Pressure
Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02779530
Brief Title
CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
Official Title
Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Barbosa Coelho
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Related Side Effects and Adverse Reactions
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
50 mg po, b.i.d for 6 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo po, b.i.d. for 6 days
Primary Outcome Measure Information:
Title
Edema
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
Time Frame
after 6 days of diclofenac and placebo
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM)
Time Frame
after 6 days of diclofenac and placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers 18-65 years-old -
Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS
-
Facility Information:
Facility Name
Unidade de Pesquisa Clínica HCRP-USP
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
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