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 Júlio 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.