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Brief Title: Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
Official Title: 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
Study ID: NCT00637975
Brief Summary: The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ospedale Serbelloni, Gorgonzola, Milano, Italy
Ospedale Civile di Legnano, Parabiago, Milano, Italy
Ospedale Sacro Cuore, Negrar, Verona, Italy
Ospedale Fatebenefratelli, Benevento, , Italy
Ospedali Riuniti, Bergamo, , Italy
Ospedale S. Orsola, Brescia, , Italy
Fatebenefratelli and Ophtalmic Hospital, Milano, , Italy
Ospedale Fatebenefratelli, Roma, , Italy
Name: Gabriella Farina, MD
Affiliation: Fatebenefratelli and Ophtalmic Hospital
Role: PRINCIPAL_INVESTIGATOR