Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

This study has been completed.
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
Associazione Progetto Oncologia UMAN.A
ClinicalTrials.gov Identifier:
NCT00637975
First received: March 12, 2008
Last updated: February 1, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Cancer
Pain
Drug: oxycodone
Drug: pregabalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Associazione Progetto Oncologia UMAN.A:

Primary Outcome Measures:
  • Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale [ Time Frame: within 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain control rate [ Time Frame: within 15 days ] [ Designated as safety issue: No ]
  • Reduction of Break Through Pain number [ Time Frame: within 15 days ] [ Designated as safety issue: No ]
  • Record of adverse events [ Time Frame: within 15 days ] [ Designated as safety issue: Yes ]
  • Reduction of allodynia in patients presenting it at T0 [ Time Frame: within 15 days ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: within 15 days ] [ Designated as safety issue: No ]
  • Assessing whether COMT and mu blood polymorphisms are associated to response [ Time Frame: within 15 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637975

Locations
Italy
Ospedale Serbelloni
Gorgonzola, Milano, Italy, 29964
Ospedale Civile di Legnano
Parabiago, Milano, Italy, 20015
Ospedale Sacro Cuore
Negrar, Verona, Italy, 37024
Ospedale Fatebenefratelli
Benevento, Italy, 82100
Ospedali Riuniti
Bergamo, Italy, 24123
Ospedale S. Orsola
Brescia, Italy, 25122
Fatebenefratelli and Ophtalmic Hospital
Milano, Italy, 20121
Ospedale Fatebenefratelli
Roma, Italy
Sponsors and Collaborators
Associazione Progetto Oncologia UMAN.A
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Gabriella Farina, MD Fatebenefratelli and Ophtalmic Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gabriella Farina, Fatebenefratelli and Ophtalmic Hospital
ClinicalTrials.gov Identifier: NCT00637975     History of Changes
Other Study ID Numbers: NEUROPAIN01, EudraCT Number 2007-005222-69
Study First Received: March 12, 2008
Last Updated: February 1, 2011
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Associazione Progetto Oncologia UMAN.A:
neuropathic pain
oxycodone
pregabalin
Patients with cancer and presenting a neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Oxycodone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 18, 2014