Trial | NCT00637975  Report issue

Title

Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
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.
Study Started
Sep 30
2007
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Feb 02
2011
Estimate

Drug oxycodone

Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops.

Drug pregabalin

Arm A - pregabalin at increasing dose starting from 50 mg/day Arm B - pregabalin 50 mg/day For 15 days or until unacceptable toxicity develops.

A Experimental

oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops

B Active Comparator

pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops

Criteria 

Inclusion Criteria:

instrumental and clinical diagnosis of every malignant neoplasm
presence of pain with a neuropathic component in the opinion of the physician
presence of pain >=4(NRS)
PS ECOG <3
written informed consent

Exclusion Criteria:

serum creatinine >2mg/ml or creatinine clearance <40 ml/min
mild or severe hepatic insufficiency
iatrogenic neuropathy caused by chemotherapeutic agents
previous allergic reactions to oxycodone and pregabalin
pregnancy or breastfeeding
No Results Posted