NCT00478179

Brief 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™).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 11, 2009

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

May 22, 2007

Last Update Submit

September 9, 2009

Conditions

Postherpetic NeuralgiaPain

Keywords

herpes zostershinglesPHNpost herpetic neuralgianeuropathic pain

Outcome Measures

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.

Interventions

Transdermal/Patch (Bupivacaine TTS [Eladur™])DRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Loma Linda, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Altoona, Pennsylvania, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Neuralgia, PostherpeticPainHerpes ZosterNeuralgia

Interventions

Administration, CutaneousTransdermal Patch

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Administration, TopicalDrug Administration RoutesDrug TherapyTherapeuticsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 11, 2009

Record last verified: 2009-09

Locations

US(7)