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CompletedNCT00181246Updated Aug 24, 2017

Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

An interventional study of Transdermal Fentanyl in Peripheral Neuropathy and Complex Regional Pain Syndromes (CRPS), sponsored by Johns Hopkins University. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Neuropathy
  • Complex Regional Pain Syndromes (CRPS)

Keywords

  • Neuropathic pain
  • Efficacy
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 53 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants

Interventions

  • DrugTransdermal Fentanyl
06

What researchers measure

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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00181246
Lead sponsor
Johns Hopkins University
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Oct 2003
Completion
Sep 2005
Last update
Aug 24, 2017

Study contacts

Srinivasa N Raja, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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