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

Drug-Related Side Effects and Adverse Reactions Clinical Trial

Official title:

Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779530
• Other study ID #: U1111-1131-8461
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2016
• Last updated: May 17, 2016
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: Healthy volunteers 18-65 years-old -

Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions

Intervention

Drug:
• Diclofenac
50 mg po, b.i.d for 6 days

Other:
• Placebo
Placebo po, b.i.d. for 6 days

Locations

Country	Name	City	State
Brazil	Unidade de Pesquisa Clínica HCRP-USP	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eduardo Barbosa Coelho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Blood Pressure	Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM)	after 6 days of diclofenac and placebo	Yes