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Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

Primary Purpose

Peripheral Neuropathy, Complex Regional Pain Syndromes (CRPS)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transdermal Fentanyl
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Neuropathic pain, Efficacy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >18 years Neuropathic pain persisting for > 3 months Pain over the immediate previous three months The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment Exclusion Criteria: A history of substance abuse Allergic reaction to an opioid Significant pain of alternate etiology other than the neuropathic pain state Severe pulmonary disease Recent myocardial infarction (within the preceding three months) Pregnancy Dementia Encephalopathy Those with life expectancy of less than six months and HIV seropositivity.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in pain intensity (0-10) and daily activity

    Secondary Outcome Measures

    Pain relief (0-100%)
    Cognition (digital symbol and grooved peg-board)
    Impairment of function (MPI) and affect (BDI)

    Full Information

    First Posted
    September 14, 2005
    Last Updated
    August 23, 2017
    Sponsor
    Johns Hopkins University
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00181246
    Brief Title
    Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Neuropathy, Complex Regional Pain Syndromes (CRPS)
    Keywords
    Neuropathic pain, Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    53 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Transdermal Fentanyl
    Primary Outcome Measure Information:
    Title
    Change in pain intensity (0-10) and daily activity
    Secondary Outcome Measure Information:
    Title
    Pain relief (0-100%)
    Title
    Cognition (digital symbol and grooved peg-board)
    Title
    Impairment of function (MPI) and affect (BDI)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years Neuropathic pain persisting for > 3 months Pain over the immediate previous three months The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment Exclusion Criteria: A history of substance abuse Allergic reaction to an opioid Significant pain of alternate etiology other than the neuropathic pain state Severe pulmonary disease Recent myocardial infarction (within the preceding three months) Pregnancy Dementia Encephalopathy Those with life expectancy of less than six months and HIV seropositivity.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Srinivasa N Raja, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

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