Herpes ZosterPhase 2/3NCT00061776
NGX-4010 for the Treatment of Postherpetic Neuralgia
A Phase 2/3 study testing Capsaicin Dermal Patch in people with Herpes Zoster and Neuralgia, run by NeurogesX at 28 sites in United States.
Trial summary
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Neuralgia, Pain
- What is being tested?
- Capsaicin Dermal Patch
- How many people
- 300 participants
- Where
- 28 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Eligibility Criteria:
- Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain.
- Must not have significant pain due to causes other than PHN (for example, arthritis).
- Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
- Must have intact and unbroken skin at the treatment area.
- Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (1-year).
- Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain.
- Must not use topical pain medications for PHN.
- Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation.
- No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
- No history or current problem with substance abuse.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
NeurogesX Investigational Site
Albany, New York, 12205
NeurogesX Investigational Site
Austin, Texas, 78758
NeurogesX Investigational Site
Boston, Massachusetts, 02115
NeurogesX Investigational Site
Dallas, Texas, 75234
NeurogesX Investigational Site
Denver, Colorado, 80218
NeurogesX Investigational Site
Eugene, Oregon, 97401
NeurogesX Investigational Site
Huntsville, Alabama, 35801
NeurogesX Investigational Site
Kansas City, Missouri, 64132
NeurogesX Investigational Site
La Jolla, California, 92037
NeurogesX Investigational Site
Las Vegas, Nevada, 89102
NeurogesX Investigational Site
Little Rock, Arkansas, 72205
NeurogesX Investigational Site
Melbourne, Florida, 32935
NeurogesX Investigational Site
Memphis, Tennessee, 93104
NeurogesX Investigational Site
Morristown, New Jersey, 07960
NeurogesX Investigational Site
Naples, Florida, 34102
NeurogesX Investigational Site
Ocala, Florida, 34471
NeurogesX Investigational Site
Palm Beach Garden, Florida, 33410
NeurogesX Investigational Site
Phoenix, Arizona, 85023
NeurogesX Investigational Site
Plantation, Florida, 33324
NeurogesX Investigational Site
Rochester, New York, 14642
NeurogesX Investigational Site
Salt Lake City, Utah, 84107
NeurogesX Investigational Site
San Antonio, Texas, 78229
NeurogesX Investigational Site
San Francisco, California, 94117
NeurogesX Investigational Site
Sarasota, Florida, 34232
NeurogesX Investigational Site
Scottsdale, Arizona
NeurogesX Investigational Site
St. Petersburg, Florida, 33702
NeurogesX Investigational Site
Tacoma, Washington, 98405
NeurogesX Investigational Site
Tucson, Arizona, 85724
About this study
Official title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).
Read the detailed description
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).
Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.
- Conditions
- Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases, Shingles
- Being tested
- Capsaicin Dermal Patch
- Keywords
- Dermal assessment, Pain measurement, Diary, Shingles, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral Nervous System Diseases/*complications
- Medical subject headings
- Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Dermal PatchDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061776
- Sponsor's protocol ID
- C108
- Status last verified
- Mar 2008
- First submitted
- 3 Jun 2003
- Last updated
- 6 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00061776
- Acronym / sponsor ID
- C108
- Conditions
- Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases, Shingles
- Keywords
- Dermal assessment, Pain measurement, Diary, Shingles, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- First posted
- 4 Jun 2003 (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.
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).
Detailed description
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).
Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Capsaicin Dermal Patch | Drug | – |
Primary outcome
Not reported in the source record.
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 6 Mar 2008.
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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.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Capsaicin Dermal Patch in people with Herpes Zoster and Neuralgia, run by NeurogesX at 28 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?
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 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 6 Mar 2008.