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
18 Years
N/A
Both
Cancer, Pain
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Outcome Time Frame:
within 15 days
Safety Issue:
No
Principal Investigator
Gabriella Farina, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fatebenefratelli and Ophtalmic Hospital
Authority:
Italy: Ethics Committee
Study ID:
NEUROPAIN01
NCT ID:
NCT00637975
Start Date:
September 2007
Completion Date:
December 2010
Related Keywords:
- Cancer
- Pain
- neuropathic pain
- oxycodone
- pregabalin
- Patients with cancer and presenting a neuropathic pain
- Neuralgia
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