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NCT Number: NCT00637975

Oxycodone and 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.

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Key information

Conditions

Cancer Neoplasms Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Fatebenefratelli, Benevento, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

Arm A - 20 mg/day

Arm B - increasing dose startnig at 20 mg/day

For 15 days or until unacceptable toxicity develops.

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.

Primary outcomes

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

    Time frame: within 15 days

Secondary outcomes

  1. Pain control rate

    Time frame: within 15 days

  2. Reduction of Break Through Pain number

    Time frame: within 15 days

  3. Record of adverse events

    Time frame: within 15 days

  4. Reduction of allodynia in patients presenting it at T0

    Time frame: within 15 days

  5. Patient satisfaction

    Time frame: within 15 days

  6. Assessing whether COMT and mu blood polymorphisms are associated to response

    Time frame: within 15 days

Sponsors and collaborators

Lead sponsor

Associazione Progetto Oncologia UMAN.A

Other

Collaborators

  • Mario Negri Institute for Pharmacological Research

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 18, 2008
Registry last updated
Feb 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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