Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

February 1, 2011 updated by: Associazione Progetto Oncologia UMAN.A

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Benevento, Italy, 82100
        • Ospedale Fatebenefratelli
      • Bergamo, Italy, 24123
        • Ospedali Riuniti
      • Brescia, Italy, 25122
        • Ospedale S. Orsola
      • Milano, Italy, 20121
        • Fatebenefratelli and Ophtalmic Hospital
      • Roma, Italy
        • Ospedale Fatebenefratelli
    • Milano
      • Gorgonzola, Milano, Italy, 29964
        • Ospedale Serbelloni
      • Parabiago, Milano, Italy, 20015
        • Ospedale Civile di Legnano
    • Verona
      • Negrar, Verona, Italy, 37024
        • Ospedale Sacro Cuore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
Drug: oxycodone

Arm A - 20 mg/day

Arm B - increasing dose startnig at 20 mg/day

For 15 days or until unacceptable toxicity develops.

Drug: pregabalin

Arm A - pregabalin at increasing dose starting from 50 mg/day

Arm B - pregabalin 50 mg/day

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

Arm A - 20 mg/day

Arm B - increasing dose startnig at 20 mg/day

For 15 days or until unacceptable toxicity develops.

Drug: pregabalin

Arm A - pregabalin at increasing dose starting from 50 mg/day

Arm B - pregabalin 50 mg/day

For 15 days or until unacceptable toxicity develops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Time Frame: within 15 days
within 15 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Progetto Oncologia UMAN.A

Collaborators

Mario Negri Institute for Pharmacological Research

Investigators

  • Principal Investigator: Gabriella Farina, MD, Fatebenefratelli and Ophtalmic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUROPAIN01
  • EudraCT Number 2007-005222-69

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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