Status:
COMPLETED
Influence of Diabetes on Tramadol Pharmacokinetics
Lead Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborating Sponsors:
University of Sao Paulo
Conditions:
Neuropathic Pain
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief 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 enantiom...
Detailed Description
Tramadol is a centrally acting analgesic that effectively relieves acute and chronic pain, including neuropathic pain in diabetic patients. The drug is available in clinical practice as a mixture of t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02246712
Start Date
June 1 2008
End Date
December 1 2011
Last Update
September 23 2014
Active Locations (1)
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1
Universidade Estadual Paulista Julio de Mesquita Filho
Araraquara, São Paulo, Brazil, 14801902