Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

Peripheral Neuropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181246
• Other study ID #: 20021288
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: August 23, 2017
• Start date: October 2003
• Est. completion date: September 2005

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Complex Regional Pain Syndromes (CRPS)
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Reflex Sympathetic Dystrophy

Intervention

Drug:
• Transdermal Fentanyl

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	PriCara, Unit of Ortho-McNeil, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity (0-10) and daily activity
Secondary	Pain relief (0-100%)
Secondary	Cognition (digital symbol and grooved peg-board)
Secondary	Impairment of function (MPI) and affect (BDI)