CClinicalTrials.gg
CompletedNCT00478179Updated Sep 11, 2009

Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia

A Phase 2 interventional study of Transdermal/Patch (Bupivacaine TTS [Eladur™]) in Postherpetic Neuralgia and Pain, sponsored by Durect. Completed at 7 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2009-09-11.

Sponsored by Durect · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

Neuropathic pain is caused by a virus commonly associated with chicken pox. This virus may become dormant in the nervous system and later reactivate causing herpes zoster, also known as "shingles". Post-herpetic neuralgia (PHN) is a persistent pain in the area of healed skin lesions. This study will test the safety and efficacy of treating PHN patients with the analgesic patch, Bupivacaine TTS (Eladur™).

02

Conditions studied

  • Postherpetic Neuralgia
  • Pain

Keywords

  • herpes zoster
  • shingles
  • PHN
  • post herpetic neuralgia
  • neuropathic pain
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 60 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Durect is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

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

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or females age 21 years or older.
  • Pain in thoracic or lumbar regions for a minimum of 90 days after crusting of Herpes Zoster (HZ) lesions.
  • Stable prescribed medications regimen (including opioids, anticonvulsants, and tricyclic antidepressants).
  • Intact, unbroken skin over the painful area to be treated.
  • Body Mass Index (BMI) no more than 35 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Active HZ lesions, dermatitis, Central Nervous System (CNS) injury.
  • Any immunosuppressed condition, including but not limited to AIDS/HIV and Hodgkin's lymphoma.
  • Pain control by nerve block or neurosurgical intervention.
  • Evidence of clinically significant hepatic, gastrointestinal, renal, hematologic, urologic, neurologic, respiratory, endocrine or cardiovascular system abnormalities, psychiatric disorders, or acute infection.
  • Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed connective tissue disease).
  • Recent use (within 30 days preceding the first treatment visit) of any topically applied pain medication, such as nonsteroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
  • Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Patients must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
  • Participation in a clinical trial of an investigational product or device within 30 days of the screening visit or concurrently during the conduct of this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
60 participants (actual)

Interventions

  • DrugTransdermal/Patch (Bupivacaine TTS [Eladur™])
06

What researchers measure

Primary outcomes

  1. Reduction of pain with mean daily pain intensity

Secondary outcomes

  1. Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.

07

Study locations

7 sites
  • La Jolla, California, United States
  • Loma Linda, California, United States
  • Santa Monica, California, United States
  • Bradenton, Florida, United States
  • Altoona, Pennsylvania, United States
  • Salt Lake City, Utah, United States
  • Tacoma, Washington, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00478179
Lead sponsor
Durect
First posted
May 24, 2007
Start date
Sep 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Sep 11, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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