Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

NCT ID: NCT00181246

Last Updated: 2017-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Neuropathy Complex Regional Pain Syndromes (CRPS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transdermal Fentanyl

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Srinivasa N Raja, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

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20021288

Identifier Type: -

Identifier Source: org_study_id

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