Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

Phase 2

Completed

• Conditions: Cancer; Pain
• Interventions: Drug: oxycodone; Drug: pregabalin

• Registration Number: NCT00637975
• Lead Sponsor: Associazione Progetto Oncologia UMAN.A

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	pregabalin	oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
A	oxycodone	oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
B	pregabalin	pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
B	oxycodone	pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops

Primary Outcome Measures

Name	Time	Method
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale	within 15 days

Secondary Outcome Measures

Name	Time	Method
Pain control rate	within 15 days
Reduction of Break Through Pain number	within 15 days
Record of adverse events	within 15 days
Reduction of allodynia in patients presenting it at T0	within 15 days
Patient satisfaction	within 15 days
Assessing whether COMT and mu blood polymorphisms are associated to response	within 15 days

Trial Locations

Locations (7)

Ospedale Sacro Cuore; 🇮🇹 Negrar, Verona, Italy

Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Ospedale S. Orsola; 🇮🇹 Brescia, Italy

Ospedale Fatebenefratelli; 🇮🇹 Roma, Italy

Ospedale Civile di Legnano; 🇮🇹 Parabiago, Milano, Italy

Ospedale Serbelloni; 🇮🇹 Gorgonzola, Milano, Italy

Fatebenefratelli and Ophtalmic Hospital; 🇮🇹 Milano, Italy