Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

NCT00637975 | Completed Phase 2 DMC

• 2 other identifiers: NEUROPAIN01EudraCT Number 2007-005222-69
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

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.

Conditions

Cancer; Pain

Keywords

neuropathic pain; oxycodone; pregabalin; Patients with cancer and presenting a neuropathic pain

Outcome Measures

Primary Outcomes (1)

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

  within 15 days

Secondary Outcomes (6)

• 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

Study Arms (2)

A

EXPERIMENTAL

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

Drug: oxycodone; Drug: pregabalin

B

ACTIVE COMPARATOR

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

Drug: oxycodone; Drug: pregabalin

Interventions

oxycodone DRUG

Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops.

A; B

pregabalin DRUG

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.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associazione Progetto Oncologia UMAN.A: lead
• Mario Negri Institute for Pharmacological Research: collaborator

Study Sites (8)

Ospedale Fatebenefratelli

Benevento, Benevento, 82100, Italy

Location

Ospedali Riuniti

Bergamo, Bergamo, 24123, Italy

Location

Ospedale S. Orsola

Brescia, Brescia, 25122, Italy

Location

Ospedale Serbelloni

Gorgonzola, Milano, 29964, Italy

Location

Fatebenefratelli and Ophtalmic Hospital

Milan, Milano, 20121, Italy

Location

Ospedale Civile di Legnano

Parabiago, Milano, 20015, Italy

Location

Ospedale Fatebenefratelli

Roma, Roma, Italy

Location

Ospedale Sacro Cuore

Negrar, Verona, 37024, Italy

Location

Related Publications (29)

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MeSH Terms

Conditions

Neoplasms; Pain; Neuralgia

Interventions

Oxycodone; Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gabriella Farina, MD

  Fatebenefratelli and Ophtalmic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 18, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 2, 2011

Record last verified: 2011-01

Locations

IT (8)