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Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use

NCT02977208 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-04-18

No results posted yet for this study

Summary

This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and other possible covariates on the kinetic disposition of GAB in patients undergoing GAB chronic treatment. Thus, patients treated with GAB, for at least one week, are being investigated.

Conditions

Interventions

PROCEDURE

Sparse blood sampling

Blood samples are being collected at times 0, 90 and 240 minutes after gabapentin administration.

PROCEDURE

Urine sampling

Urine samples are being collected during the dosing interval, only in patients hospitalized at Hospital Estadual de Américo Brasiliense (HEAB).

PROCEDURE

DNA extraction

Blood sample are being collected for DNA extraction. DNA are being extracted from the whole blood of all patients for genotyping of the SLC22A2 c.808G\>T and SLC22A4 c.1507C\>T polymorphisms

DRUG

Gabapentin

All patients undergoing chronic treatment with gabapentin are being recruited.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • São Paulo State University

    lead OTHER

Principal Investigators

  • Fabíola D. Eckeli, Prof. · University of Sao Paulo

  • Edgar Ianhez Júnior · Hospital Estadual de Américo Brasiliense

  • Natália V. de Moraes, Prof. · Universidade Estadual Paulista Júlio de Mesquita Filho

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02977208 on ClinicalTrials.gov