Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

Associazione Progetto Oncologia UMAN.A

Status and phase: Completed; Phase 2

Conditions: Cancer; Pain

Treatments: Drug: pregabalin; Drug: oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT00637975

NEUROPAIN01

EudraCT Number 2007-005222-69

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

A

Experimental group

Description:

oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops

Treatment:

Drug: oxycodone

Drug: pregabalin

B

Active Comparator group

Description:

pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops

Treatment:

Drug: oxycodone

Drug: pregabalin