Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin

Last updated: May 30, 2013
Sponsor: Turku University Hospital
Overall Status: Trial Not Available

Phase

4

Condition

Postherpetic Neuralgia

Pain (Pediatric)

Pain

Treatment

N/A

Clinical Study ID

NCT01116531
60/180/2009
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronic (≥ 6 months) neuropathic pain due to postherpetic neuralgia or diabeticpolyneuropathy

  • Pain intensity ≥ 4 on a numerical scale of 0-10

  • Informed consent

Exclusion

Exclusion Criteria:

  • Clinically significant abnormalities in laboratory screening

  • Pregnancy

  • Depression

  • Use of strong opioids (morphine, oxycodone, fentanyl, hydromorphone, methadone)

  • A previous history of intolerance or allergy to the study drugs or to relatedcompounds and additives

  • Existing or history of seizures, haematological disorders, clinically significantrenal, hepatic, respiratory, cardiac or psychiatric disease, dementia, drug allergy

  • Previous or present alcoholism, drug abuse, psychological or other emotional problemsor cognitive impairment that are likely to invalidate informed consent or limit theability of the subject to comply with protocol requirements

  • Concomitant drug therapy known to cause significant enzyme induction or inhibition ofCYP 1A2, 2D6, 3A4, 2B6, drugs metabolised by CYP2D6 enzyme, antidepressants,MAO-inhibitors, non-steroidal anti-inflammatory analgesics.

Study Design

Study Start date:
April 01, 2010
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital

    Turku, 20520
    Finland

    Site Not Available

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