G53.0 Vyöruusun jälkeinen hermosärky G63.2 Diabeteksen monihermosairaus MedDRA version: 9.1 Level: LLT Classification code 10036377 Term: Postherpetic polyneuropathy MedDRA version: 9.1 Level: LLT Classification code 10012680 Term: Diabetic neuropathy
Conditions
Interventions
Trade Name: Tramal retard
Pharmaceutical Form: Tablet
INN or Proposed INN: TRAMADOL
CAS Number: 27203925
Trade Name: Lyrica
Pharmaceutical Form: Capsule*
INN or Proposed INN: PREGABALIN
CAS Number: 1
Sponsors
University of Turku
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to investigate the pharmacokinetics and pharmacodynamic interaction of oral tramadol with duloxetine and pregabalin in patients with chronic neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy.;Secondary Objective: ;Primary end point(s): -Pharmacokinetic measurements: Tramadol and O-desmethyltramadol -Pharmacodynamic measurements: Plasma 5-HT concentration, Platelet function, pain intensity, use of rescue medication, behavioral serotonergic effect, global improvement ajd satisfaction with treatment | — |
Countries
Finland
Outcome results
None listed