Drug-Related Side Effects and Adverse Reactions
Conditions
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.
Interventions
DRUGDiclofenac
50 mg po, b.i.d for 6 days
OTHERPlacebo
Placebo po, b.i.d. for 6 days
Sponsors
Eduardo Barbosa Coelho
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers 18-65 years-old -
Exclusion criteria
Use of drugs and without clinical history of adverse effects of NSAIDS \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Brazil
Outcome results
None listed