Postherpetic NeuralgiaPhase 2NCT00478179
Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia
A Phase 2 study testing Transdermal/Patch (Bupivacaine TTS [Eladur™]) in people with Postherpetic Neuralgia and Pain, run by Durect at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Pain
- What is being tested?
- Transdermal/Patch (Bupivacaine TTS [Eladur™])
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Altoona, Pennsylvania
Study site
Bradenton, Florida
Study site
La Jolla, California
Study site
Loma Linda, California
Study site
Salt Lake City, Utah
Study site
Santa Monica, California
Study site
Tacoma, Washington
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Two-Way Cross-Over Study of Analgesic Efficacy of Bupivacaine Transdermal Therapeutic System in Patients With Post-Herpetic Neuralgia
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™).
- Conditions
- Postherpetic Neuralgia, Pain
- Being tested
- Transdermal/Patch (Bupivacaine TTS [Eladur™])
- Keywords
- herpes zoster, shingles, PHN, post herpetic neuralgia, neuropathic pain
- Medical subject headings
- Neuralgia, Postherpetic, Pain, Herpes Zoster, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal/Patch (Bupivacaine TTS [Eladur™])Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain with mean daily pain intensity
Secondary outcomes (1)
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478179
- Sponsor's protocol ID
- CLIN005-0009
- Status last verified
- Sep 2009
- First submitted
- 22 May 2007
- Last updated
- 11 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Two-Way Cross-Over Study of Analgesic Efficacy of Bupivacaine Transdermal Therapeutic System in Patients With Post-Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00478179
- Acronym / sponsor ID
- CLIN005-0009
- Conditions
- Postherpetic Neuralgia, Pain
- Keywords
- herpes zoster, shingles, PHN, post herpetic neuralgia, neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal/Patch (Bupivacaine TTS [Eladur™]) | Drug | – |
Primary outcome
Reduction of pain with mean daily pain intensity
1 secondary outcome
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal/Patch (Bupivacaine TTS [Eladur™]) in people with Postherpetic Neuralgia and Pain, run by Durect at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain with mean daily pain intensity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2009.