Status:
COMPLETED
Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
Lead Sponsor:
Associazione Progetto Oncologia UMAN.A
Collaborating Sponsors:
Mario Negri Institute for Pharmacological Research
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00637975
Start Date
September 1 2007
End Date
December 1 2010
Last Update
February 2 2011
Active Locations (8)
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1
Ospedale Fatebenefratelli
Benevento, Benevento, Italy, 82100
2
Ospedali Riuniti
Bergamo, Bergamo, Italy, 24123
3
Ospedale S. Orsola
Brescia, Brescia, Italy, 25122
4
Ospedale Serbelloni
Gorgonzola, Milano, Italy, 29964