Efficacy, safety, tolerability and pharmacokinetics of concomitant administration of tramadol with duloxetine or pregabalin: a randomized controlled flexible-dose study in patients with neuropathic pain

niversity of Turku0 sites40 target enrollmentJune 8, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: G53.0 Vyöruusun jälkeinen hermosärkyG63.2 Diabeteksen monihermosairaus
Sponsor: niversity of Turku
Enrollment: 40
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

June 8, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Turku

•1\.Males and females aged 18\-70 years
•2\.Chronic (\= 6 months) neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy
•3\.Pain intensity \= 4 on a numerical scale of 0\-10
•4\.Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•1\.Clinically significant abnormalities in laboratory screening: CBC (including hemoglobin, hematocrit, differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase, BUN, creatinine, U\-gluc and U\-prot, ECG
•2\.GFR \< 30 ml/min
•3\.A positive pregnancy test for women or nursing
•4\.Depression (DEPS score \> 11/30\).
•5\.Use of strong opioids (morphine, oxycodone, fentanyl, hydromorphone, methadone)
•6\.A previous history of intolerance or allergy to the study drugs or to related compounds and additives
•7\.Existing or history of seizures, haematological disorders, clinically significant renal, hepatic, respiratory, cardiac or psychiatric disease, dementia, drug allergy.
•8\.Previous or present alcoholism, drug abuse, psychological or other emotional problems or cognitive impairment that are likely to invalidate informed consent or limit the ability of the subject to comply with protocol requirements
•9\.Concomitant drug therapy known to cause significant enzyme induction or inhibition of CYP 1A2, 2D6, 3A4, 2B6, drugs metabolised by CYP2D6 enzyme, antidepressants, MAO\-inhibitors, non\-steroidal anti\-inflammatory analgesics. A detailed list of such medication is given in Appendix 2\.
•10\.Donation of blood for 4 weeks prior to the study