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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03047278
Other study ID # GBPDIABETCET
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2015
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Gabapentin (GBP), anticonvulsant used to neuropathic pain treatment, is mainly eliminated unchanged in urine. Renal active tubular secretion has been suggested to contribute on GBP excretion by renal excretion. Studies performed on rats with experimental diabetes suggest that hyperglycemia reduces the activity of organic cation transporters (Oct). Thus, the aim of the study was to investigate the role of OCTs on kinetic disposition and pharmacodynamics of GBP in patients with neuropathic pain and to verify the regulation of these transporters' activity by glycemic control in diabetes. A cross-over clinical study was performed in patients with neuropathic pain (n=10, Control) to evaluate the influence of CTZ on GBP kinetic disposition. To evaluate the effect of glycemic control, patients with controlled DM2 (DC, n=9) and uncontrolled DM2 (DNC, n=10) were investigated. All participants investigated had neuropathic pain of intensity ≥ 4 evaluated by analogue visual scale (EVA) and were treated with oral single-dose of 300 mg of GBP (Phase 1) or cetirizine (20 mg/day) for 5 days and single-dose of GBP on the last day (Phase 2). Only participants of Control group participated of Phase 2. Serial blood and urine samples were collected up to 36 hours after GBP administration. The intensity of pain was evaluated at the same time of blood sampling, using the visual analog scale. GBP concentration in plasma and urine was validated by JPLC-UV. All participants were genotyped for polymorphisms SLC22A2 808G>T and SLC22A4 1507C>T. The pharmacokinetic parameters were estimated by non-compartmental analysis.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date July 1, 2019
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- Adult patients, both gender

- Patients with neuropathic pain with score = 4 in visual analog scale

- Patients with controlled type 2 diabetes (glycated hemoglobin = 8.0%) and diabetic neuropathy with score = 4 in visual analog scale

- Patients with uncontrolled type 2 diabetes (glycated hemoglobin = 8.0%) and diabetic neuropathy with score = 4 in visual analog scale

- Patients that suspend the use of analgesics for 10 times half-life before starting the protocol

Exclusion Criteria:

- Patients with acute or chronicle severe renal failure (creatinine clearance = 30 mL/min)

- Patients with gastrointestinal diseases

- Patients with history of alcohol and drug abuse

- Patients with acute myocardial insufficiency

- Patients with another kind of chronicle pain as severe as neuropathic pain

- Patients in chronicle use of drugs that interact with gabapentin (antacids and cimetidine)

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Natalia Valadares de Moraes University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameter (AUC) Area under the plasma concentration versus time (AUC) Up to 36 hours after gabapentin (300 mg) administration
Secondary Pharmacokinetic parameter (Total clearance) Total clearance Up to 36 hours after gabapentin (300 mg) administration
Secondary Pharmacokinetic parameter (Renal clearance) Renal clearance Up to 36 hours after gabapentin (300 mg) administration
Secondary Pharmacokinetic parameter (Vd) Volume of distribution (Vd) Up to 36 hours after gabapentin (300 mg) administration
Secondary Pharmacokinetic parameter (Elimination half-life) Elimination half-life Up to 36 hours after gabapentin (300 mg) administration
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