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

• Conditions: G53.0 Vyöruusun jälkeinen hermosärkyG63.2 Diabeteksen monihermosairaus; MedDRA version: 9.1Level: LLTClassification code 10036377Term: Postherpetic polyneuropathy; MedDRA version: 9.1Level: LLTClassification code 10012680Term: Diabetic neuropathy

• Registration Number: EUCTR2009-013061-26-FI
• Lead Sponsor: niversity of Turku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>-Pharmacodynamic measurements: Plasma 5-HT concentration, Platelet function, pain intensity, use of rescue medication, behavioral serotonergic effect, global improvement ajd satisfaction with treatment