Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are
the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less
then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often
combined with opioids in the analgesic regimen of patients with neuropathic cancer pain.
This approach is suggested by well-established guidelines, but the analgesic benefit and the
safety of pregabalin and oxycodone in combination is not yet documented.
The aim of this study is to assess the activity and tolerability of the addition of
pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
within 15 days
Gabriella Farina, MD
Fatebenefratelli and Ophtalmic Hospital
Italy: Ethics Committee