Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181246
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Johns Hopkins University:
Neuropathic pain
Efficacy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014