Overview

Influence of Diabetes on Tramadol Pharmacokinetics

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study aimed to investigate the influence of uncontrolled type 1 and type 2 diabetes mellitus (DM) on the kinetic disposition, metabolism and pharmacokinetics-pharmacodynamics of tramadol enantiomers in patients with neuropathic pain. Thus, nondiabetic patients (control group, n = 12), patients with type 1 DM (n = 9), and patients with type 2 DM (n = 9), all with neuropathic pain and phenotyped as extensive metabolizers of cytochrome P450 2D6 (CYP2D6) who were treated with a single oral dose of 100 mg racemic tramadol were investigated.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universidade Estadual Paulista JĂșlio de Mesquita Filho
Collaborator:
University of Sao Paulo
Treatments:
Metoprolol
Midazolam
Tramadol
Criteria
Inclusion Criteria:

- Adult patients, both gender

- Patients with self-reported neuropathic pain (score >4 in a 0-10 visual analog scale)

- Patients with normal renal function (creatinine clearance >60 mL/min)

Exclusion Criteria:

- Patients with nociceptive somatic pain, visceral or autonomic associated during the
study period;

- Patients with morbid obesity (BMI> 40), congestive heart failure, severe hypertension

- Patients who have had acute myocardial infarction or accident stroke less than 6
months of the period of investigation.

- Patients with chronic obstructive pulmonary disease

- Patients who were in use of analgesics, CYP2D6 inhibitors or CYP3A4 inducers or
inhibitors were excluded.

- Pregnant and lactating patients were excluded.