Type 2 Diabetes Mellitus Clinical Trial
Official title:
Gabapentin Kinetic Disposition and Renal Excretion: Role of Transporters for Organic Cations and the Effect of Glycemic Control in Patients With Neuropathic Pain.
Verified date | July 2019 |
Source | Universidade Estadual Paulista Júlio de Mesquita Filho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Natalia Valadares de Moraes | University of Sao Paulo |
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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