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

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Natalia Valadares de Moraes
• Collaborator: University of Sao Paulo
• Treatments: Cetirizine; Gabapentin; gamma-Aminobutyric Acid

Criteria

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)