CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
- Conditions
- Drug-Related Side Effects and Adverse Reactions
- Interventions
- Other: Placebo
- Registration Number
- NCT02779530
- Lead Sponsor
- Eduardo Barbosa Coelho
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Healthy volunteers 18-65 years-old -
Use of drugs and without clinical history of adverse effects of NSAIDS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - Diclofenac Diclofenac -
- Primary Outcome Measures
Name Time Method Edema 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 Outcome Measures
Name Time Method Blood Pressure 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)
Trial Locations
- Locations (1)
Unidade de Pesquisa Clínica HCRP-USP
🇧🇷Ribeirao Preto, Sao Paulo, Brazil