Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

This study has been completed.

Sponsors and Collaborators:	Johns Hopkins University PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181246

Purpose

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.

Condition	Intervention
Peripheral Neuropathy, CRPS1 and Postamputation Pain.	Drug: Transdermal Fentanyl

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Fentanyl Citrate Fentanyl

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Johns Hopkins University:

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)

Estimated Enrollment:	53
Study Start Date:	October 2003
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181246

Sponsors and Collaborators

Johns Hopkins University

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Principal Investigator:

Srinivasa N Raja, MD

Johns Hopkins University

More Information

Study ID Numbers:	20021288
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00181246
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Neuropathic pain
Efficacy

Study placed in the following topic categories:

Fentanyl
Neuromuscular Diseases
Complex Regional Pain Syndromes
Peripheral Nervous System Diseases
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009