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Methadone in Post-Herpetic Neuralgia Pain (NPH)

Primary Purpose

Post-herpetic Neuralgia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methadone
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-herpetic Neuralgia focused on measuring neuropathic pain,, post-herpetic neuralgia,, methadone,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic (>6 months) symptomatic PHN
  • with visual analogical scale >40/100mm
  • use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)

Exclusion Criteria:

  • Don't full the criteria above

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Methadone

    Placebo

    Arm Description

    in this arm patients will take methadone 5mg.

    in this arm patients will take placebo pills.

    Outcomes

    Primary Outcome Measures

    Change in baseline Pain
    Assessing by verbal analog scale (VAS)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2012
    Last Updated
    March 14, 2013
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01752699
    Brief Title
    Methadone in Post-Herpetic Neuralgia Pain
    Acronym
    NPH
    Official Title
    Methadone in Post-Herpetic Neuralgia Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1998 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-herpetic Neuralgia
    Keywords
    neuropathic pain,, post-herpetic neuralgia,, methadone,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Methadone
    Arm Type
    Experimental
    Arm Description
    in this arm patients will take methadone 5mg.
    Arm Title
    Placebo
    Arm Type
    Experimental
    Arm Description
    in this arm patients will take placebo pills.
    Intervention Type
    Drug
    Intervention Name(s)
    Methadone
    Intervention Description
    patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    patients with post-herpetic neuralgia take placebo to treat the pain symptoms.
    Primary Outcome Measure Information:
    Title
    Change in baseline Pain
    Description
    Assessing by verbal analog scale (VAS)
    Time Frame
    baseline (visit inclusion) and three moths latter

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic (>6 months) symptomatic PHN with visual analogical scale >40/100mm use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids) Exclusion Criteria: Don't full the criteria above

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23917673
    Citation
    Teixeira MJ, Okada M, Moscoso AS, Puerta MY, Yeng LT, Galhardoni R, Tengan S, Andrade DC. Methadone in post-herpetic neuralgia: A pilot proof-of-concept study. Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.
    Results Reference
    derived

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    Methadone in Post-Herpetic Neuralgia Pain

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