Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
NCT ID: NCT02977208
Last Updated: 2018-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
66 participants
INTERVENTIONAL
2016-09-30
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Homozygous for the wild type allele
Patients with 18 years old or older with epilepsy, neuropathic pain or any chronic pain undergoing chronic treatment with gabapentin are being recruited.
Sparse blood sampling are being collected up to 4 h after administration of the drug for pharmacokinetic study. Urine sampling are being collected during the dosing interval, only in patients hospitalized at the Hospital Estadual de Américo Brasiliense (HEAB). 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.
Sparse blood sampling
Blood samples are being collected at times 0, 90 and 240 minutes after gabapentin administration.
Urine sampling
Urine samples are being collected during the dosing interval, only in patients hospitalized at Hospital Estadual de Américo Brasiliense (HEAB).
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
Gabapentin
All patients undergoing chronic treatment with gabapentin are being recruited.
Homo- or heterozygous for rare alleles
Patients with 18 years old or older with epilepsy, neuropathic pain or any chronic pain undergoing chronic treatment with gabapentin are being recruited.
Sparse blood sampling are being collected up to 4 h after administration of the drug for pharmacokinetic study. Urine sampling are being collected during the dosing interval, only in patients hospitalized at the Hospital Estadual de Américo Brasiliense (HEAB). 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.
Sparse blood sampling
Blood samples are being collected at times 0, 90 and 240 minutes after gabapentin administration.
Urine sampling
Urine samples are being collected during the dosing interval, only in patients hospitalized at Hospital Estadual de Américo Brasiliense (HEAB).
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
Gabapentin
All patients undergoing chronic treatment with gabapentin are being recruited.
Interventions
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Sparse blood sampling
Blood samples are being collected at times 0, 90 and 240 minutes after gabapentin administration.
Urine sampling
Urine samples are being collected during the dosing interval, only in patients hospitalized at Hospital Estadual de Américo Brasiliense (HEAB).
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
Gabapentin
All patients undergoing chronic treatment with gabapentin are being recruited.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing chronic use of gabapentin (at least one week).
Exclusion Criteria
* Patients who were in use of OCT2 and OCTN1 inhibitors.
* Patients who disagree to continue the study.
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
São Paulo State University
OTHER
Responsible Party
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Priscila Akemi Yamamoto
Principal investigator
Principal Investigators
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Fabíola D. Eckeli, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Edgar Ianhez Júnior
Role: PRINCIPAL_INVESTIGATOR
Hospital Estadual de Américo Brasiliense
Natália V. de Moraes, Prof.
Role: STUDY_CHAIR
Universidade Estadual Paulista Júlio de Mesquita Filho
Locations
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Universidade Estadual Paulista Júlio de Mesquita Filho
Araraquara, São Paulo, Brazil
Countries
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Other Identifiers
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OCTGab
Identifier Type: -
Identifier Source: org_study_id
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