Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

Condition(s) targeted: Cancer; Pain

Intervention: oxycodone and pregabalin (Drug); oxycodone and pregabalin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Associazione Progetto Oncologia UMAN.A

Official(s) and/or principal investigator(s):
Gabriella Farina, MD, Principal Investigator, Affiliation: Fatebenefratelli and Ophtalmic Hospital

Overall contact:
Gabriella Farina, MD, Phone: +39 02 6363 2223, Email: gabriella.farina@fbf.milano.it

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale

Secondary outcome:

Pain control rate

Reduction of Break Through Pain number

Record of adverse events

Reduction of allodynia in patients presenting it at T0

Patient satisfaction

Assessing whether COMT and mu blood polymorphisms are associated to response

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Gabriella Farina, MD, Phone: +39 02 6363 2223, Email: gabriella.farina@fbf.milano.it

Ospedale Fatebenefratelli, Benevento 82100, Italy; Recruiting
Antonio Febbraro, MD, Phone: +39 3403371731, Email: antoniofebbraro@virgilio.it
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; Not yet recruiting
Giordano Beretta, MD, Phone: +39 0302971224, Email: gdberetta@fatebenefratelli.it
Giordano Beretta, MD, Principal Investigator

Fatebenefratelli and Ophtalmic Hospital, Milano 20121, Italy; Recruiting
Gabriella Farina, MD, Phone: +39 0263632223, Email: gabriella.farina@fbf.milano.it
Gabriella Farina, MD, Principal Investigator
Marina C Garassino, MD, Sub-Investigator

Ospedale Fatebenefratelli, Roma, Italy; Recruiting
Enrico Breda, MD, Phone: +39 330291335, Email: enricobreda@libero.it
Enrico Breda, MD, Principal Investigator

Ospedale Civile di Legnano, Parabiago, Milano 20015, Italy; Not yet recruiting
Elena Collovà, MD, Phone: +39 3478632345, Email: laelena75@hotmail.com
Elena Collovà, MD, Sub-Investigator
Sergio Fava, MD, Principal Investigator

Ospedale Serbelloni, Gorgonzola, Milano 29964, Italy; Not yet recruiting
Luciano Isa, MD, Phone: +39 0295707207, Email: luciano.isa@aospmelegnano.it
Luciano Isa, MD, Principal Investigator

Ospedale Sacro Cuore, Negrar, Verona 37024, Italy; Not yet recruiting
Roberto Magarotto, MD, Phone: +39 0456013111, Email: roberto.magarotto@sacrocuore.it
Roberto Magarotto, MD, Sub-Investigator
Marco Venturini, MD, Principal Investigator
Francesca Coati, Sub-Investigator

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Starting date: September 2007
Ending date: March 2010
Last updated: July 11, 2008