Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
Information source: Associazione Progetto Oncologia UMAN.A
Information obtained from ClinicalTrials.gov on October 04, 2010
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
Gabriella Farina, MD, Phone: +39 02 6363 2223, Email: firstname.lastname@example.org
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, Control: Active Control, 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
Gabriella Farina, MD, Phone: +39 02 6363 2223, Email: email@example.com
Ospedale Fatebenefratelli, Benevento 82100, Italy; Recruiting
Antonio Febbraro, MD, Phone: +39 3403371731, Email: firstname.lastname@example.org
Antonio Febbraro, MD, Principal Investigator
Ospedali Riuniti, Bergamo 24123, Italy; Not yet recruiting
Roberto Labianca, MD, Phone: +39 035269111, Email: RLabianca@ospedaliriuniti.bergamo.it
Roberto Labianca, MD, Principal Investigator
Cecilia Moro, MD, Sub-Investigator
Ospedale S. Orsola, Brescia 25122, Italy; Recruiting
Giordano Beretta, MD, Phone: +39 0302971224, Email: email@example.com
Giordano Beretta, MD, Principal Investigator
Fatebenefratelli and Ophtalmic Hospital, Milano 20121, Italy; Recruiting
Gabriella Farina, MD, Phone: +39 0263632223, Email: firstname.lastname@example.org
Aurora Rizzo, PharmD, Phone: +39 0263632223, Email: email@example.com
Gabriella Farina, MD, Principal Investigator
Marina C Garassino, MD, Sub-Investigator
Ospedale Fatebenefratelli, Roma, Italy; Recruiting
Enrico Breda, MD, Phone: +39 330291335, Email: firstname.lastname@example.org
Enrico Breda, MD, Principal Investigator
Ospedale Serbelloni, Gorgonzola, Milano 29964, Italy; Recruiting
Luciano Isa, MD, Phone: +39 0295707207, Email: email@example.com
Luciano Isa, MD, Principal Investigator
Claudia Carbone, MD, Sub-Investigator
Ospedale Civile di Legnano, Parabiago, Milano 20015, Italy; Recruiting
Elena Collovà, MD, Phone: +39 3478632345, Email: firstname.lastname@example.org
Elena Collovà, MD, Sub-Investigator
Sergio Fava, MD, Principal Investigator
Ospedale Sacro Cuore, Negrar, Verona 37024, Italy; Recruiting
Roberto Magarotto, MD, Phone: +39 0456013111, Email: email@example.com
Roberto Magarotto, MD, Sub-Investigator
Marco Venturini, MD, Principal Investigator
Francesca Coati, Sub-Investigator
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Starting date: September 2007
Last updated: January 29, 2009