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Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00637975
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : February 2, 2011
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
Associazione Progetto Oncologia UMAN.A

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 18, 2008
Last Update Posted Date February 2, 2011
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale [ Time Frame: within 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00637975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • Pain control rate [ Time Frame: within 15 days ]
  • Reduction of Break Through Pain number [ Time Frame: within 15 days ]
  • Record of adverse events [ Time Frame: within 15 days ]
  • Reduction of allodynia in patients presenting it at T0 [ Time Frame: within 15 days ]
  • Patient satisfaction [ Time Frame: within 15 days ]
  • Assessing whether COMT and mu blood polymorphisms are associated to response [ Time Frame: within 15 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Pain
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: A
    oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
    Interventions:
    • Drug: oxycodone
    • Drug: pregabalin
  • 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
    Interventions:
    • Drug: oxycodone
    • Drug: pregabalin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 17, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00637975
Other Study ID Numbers  ICMJE NEUROPAIN01
EudraCT Number 2007-005222-69
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gabriella Farina, Fatebenefratelli and Ophtalmic Hospital
Study Sponsor  ICMJE Associazione Progetto Oncologia UMAN.A
Collaborators  ICMJE Mario Negri Institute for Pharmacological Research
Investigators  ICMJE
Principal Investigator: Gabriella Farina, MD Fatebenefratelli and Ophtalmic Hospital
PRS Account Associazione Progetto Oncologia UMAN.A
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP