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Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181246
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 24, 2017
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Complex Regional Pain Syndromes (CRPS) Drug: Transdermal Fentanyl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in pain intensity (0-10) and daily activity

Secondary Outcome Measures :
  1. Pain relief (0-100%)
  2. Cognition (digital symbol and grooved peg-board)
  3. Impairment of function (MPI) and affect (BDI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181246

Sponsors and Collaborators
Johns Hopkins University
PriCara, Unit of Ortho-McNeil, Inc.
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Principal Investigator: Srinivasa N Raja, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT00181246     History of Changes
Other Study ID Numbers: 20021288
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
Neuropathic pain

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autonomic Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General