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OpenTrials
Completed

NCT Number: NCT00181246

Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

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.

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Key information

Conditions

Peripheral Neuropathy Autonomic Nervous System Diseases Complex Regional Pain Syndromes Complex Regional Pain Syndromes (CRPS) Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transdermal fentanyl

Drug

Primary outcomes

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

Secondary outcomes

  1. Pain relief (0-100%)

  2. Cognition (digital symbol and grooved peg-board)

  3. Impairment of function (MPI) and affect (BDI)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • PriCara, Unit of Ortho-McNeil, Inc.

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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