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Transporters for Organic Cations and Glycemic Control in Patients With Neuropathic Pain.

NCT03047278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-07-05

No results posted yet for this study

Summary

This study aimed to investigate the influence of the glycemic control of type 2 diabetes (DM2) and of cetirizine (OCTs inhibitor) on gabapentin kinetics disposition and pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus, non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=9) and patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in pain visual analog scale (0-10) were investigated.

Conditions

Interventions

PROCEDURE

Serial Blood Samples

Serial blood samples were collected at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours after gabapentin administration, for all patients.

PROCEDURE

Serial Urine Samples

Serial urine samples were collected at intervals 0-8 hours, 8-16 hours, 16-24 hours and 24-36 hours after gabapentin administration, for all patients.

DRUG

Gabapentin 300 mg

All patients were treated with oral single dose of gabapentin 300 mg.

DRUG

Cetirizine Hydrochloride 10 mg

Patients of control group were treated with cetirizine hydrochloride, 10 mg, twice as day, orally, for five days.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Natalia Valadares de Moraes

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2018-05-01
Completion
2019-07-01

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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 NCT03047278 on ClinicalTrials.gov