Clinical trial NCT00637975: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Pain
Keywords: neuropathic pain
oxycodone
pregabalin
Patients with cancer and presenting a neuropathic pain
Lead sponsor: Associazione Progetto Oncologia UMAN.A
Sponsor class: OTHER
Collaborators: name: Mario Negri Institute for Pharmacological Research
First posted: 2008-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
timeFrame: within 15 days
Secondary outcomes:
measure: Pain control rate
timeFrame: within 15 days
measure: Reduction of Break Through Pain number
timeFrame: within 15 days
measure: Record of adverse events
timeFrame: within 15 days
measure: Reduction of allodynia in patients presenting it at T0
timeFrame: within 15 days
measure: Patient satisfaction
timeFrame: within 15 days
measure: Assessing whether COMT and mu blood polymorphisms are associated to response
timeFrame: within 15 days
Other outcomes:
Locations:
city: Gorgonzola
country: Italy
facility: Ospedale Serbelloni
state: Milano
city: Parabiago
country: Italy
facility: Ospedale Civile di Legnano
state: Milano
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore
state: Verona
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Brescia
country: Italy
facility: Ospedale S. Orsola
city: Milano
country: Italy
facility: Fatebenefratelli and Ophtalmic Hospital
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli
Study officials:
affiliation: Fatebenefratelli and Ophtalmic Hospital
name: Gabriella Farina, MD
role: PRINCIPAL_INVESTIGATOR
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