NCT00181246

Completed

Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pai...

Johns Hopkins University Source

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Other study identifiers

Sponsor study identifier

20021288

Study Type

interventional

Reported enrollment (type unavailable)

53

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

September 2005

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 53 participants
Study completion date: September 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
September 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 14, 2005
Actual (reported)
First Posted
September 16, 2005
Actual (reported)

Last Updated: August 24, 2017
Status Verified: August 2017
Last Update Submitted: August 23, 2017

Conditions

Peripheral Neuropathy Complex Regional Pain Syndromes (CRPS)

Keywords

Neuropathic painEfficacy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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

Interventions

Transdermal FentanylDrug

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age \>18 years
Neuropathic pain persisting for \> 3 months

Sponsors & Collaborators

PriCara, Unit of Ortho-McNeil, Inc.
Industrycollaborator
Johns Hopkins University
Otherlead

MeSH Terms

Conditions

Peripheral Nervous System DiseasesComplex Regional Pain SyndromesNeuralgia

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesAutonomic Nervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Srinivasa N Raja, MD
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

October 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

September 2005

Date type not reported

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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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

August 24, 2017

Record last verified: 2017-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00181246
Data provider: ClinicalTrials.gov
Source updated: 2017-08-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:00 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record