NCT00181246

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

First QC Date

September 14, 2005

Last Update Submit

August 23, 2017

Conditions

Peripheral NeuropathyComplex Regional Pain Syndromes (CRPS)

Keywords

Neuropathic painEfficacy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Pain relief (0-100%)

  • Cognition (digital symbol and grooved peg-board)

  • Impairment of function (MPI) and affect (BDI)

Interventions

Transdermal FentanylDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Nervous System DiseasesComplex Regional Pain SyndromesNeuralgia

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesAutonomic Nervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Srinivasa N Raja, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Study Completion

September 1, 2005

Last Updated

August 24, 2017

Record last verified: 2017-08