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
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Neuropathic pain, Efficacy
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.
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
NCT ID
NCT00181246
First Posted
September 14, 2005
Last Updated
August 23, 2017
Sponsor
Johns Hopkins University
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
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
Learn more about this trial
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
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