Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
Information source: Associazione Progetto Oncologia UMAN.A
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pain
Intervention: oxycodone (Drug); pregabalin (Drug)
Phase: Phase 2
Sponsored by: Associazione Progetto Oncologia UMAN.A
Official(s) and/or principal investigator(s):
Gabriella Farina, MD, Principal Investigator, Affiliation: Fatebenefratelli and Ophtalmic Hospital
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.
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Pain control rate
Reduction of Break Through Pain number
Record of adverse events
Reduction of allodynia in patients presenting it at T0
Assessing whether COMT and mu blood polymorphisms are associated to response
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.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
Ospedale Fatebenefratelli, Benevento 82100, Italy
Ospedali Riuniti, Bergamo 24123, Italy
Ospedale S. Orsola, Brescia 25122, Italy
Fatebenefratelli and Ophtalmic Hospital, Milano 20121, Italy
Ospedale Fatebenefratelli, Roma, Italy
Ospedale Serbelloni, Gorgonzola, Milano 29964, Italy
Ospedale Civile di Legnano, Parabiago, Milano 20015, Italy
Ospedale Sacro Cuore, Negrar, Verona 37024, Italy
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Starting date: September 2007
Last updated: February 1, 2011