Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin
Status:
Withdrawn
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Tramadol is an opioid analgesic, which is widely used in the treatment of acute and
neuropathic pain. Treatment of neuropathic pain often requires a combination of pain
medications due to the complex nature of neuropathic pain and frequent inadequate response to
drug treatment. Common drugs used concomitantly with tramadol are SNRI antidepressant
duloxetine and anticonvulsants such as pregabalin. Both tramadol and duloxetine have
serotonergic effects and duloxetine has also a potential to inhibit metabolism of tramadol.
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. All subjects will
receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind
order. Primary end point is O-desmethyltramadol concentration.