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 个研究点目标入组 40 人开始时间: 2009年6月8日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•11.Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study

发起方

niversity of Turku