Herpes ZosterPhase 2NCT00082316
Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
A Phase 2 study testing Capsaicin Dermal Patch in people with Herpes Zoster and Neuralgia, run by NeurogesX at 17 sites in United States.
Trial summary
This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. 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
- Not given
- Where
- 17 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Eligibility Criteria:
- Must have had for at least 3 months painful diabetic neuropathy, or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average.
- Must not have significant pain due to other causes (for example, arthritis).
- Must have intact 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 (12 weeks).
- Must not use topical pain medications on painful areas.
- Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation.
- Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
- 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
NeurogesX Investigational Site
Clearwater, Florida, 33765
NeurogesX Investigational Site
Denver, Colorado, 80209
NeurogesX Investigational Site
Duncansville, Pennsylvania, 16635
NeurogesX Investigational Site
Fountain Valley, California, 92708
NeurogesX Investigational Site
Greensboro, New Jersey, 27408
NeurogesX Investigational Site
Huntsville, Alabama, 35801
NeurogesX Investigational Site
Los Gatos, California, 95032
NeurogesX Investigational Site
Mobile, Alabama, 36608
NeurogesX Investigational Site
New Port Richey, Florida, 34652
NeurogesX Investigational Site
North Miami, Florida, 33161
NeurogesX Investigational Site
Phoenix, Arizona, 85023
NeurogesX Investigational Site
Plantation, Florida, 33324
NeurogesX Investigational Site
Salt Lake City, Utah, 84106
NeurogesX Investigational Site
San Antonio, Texas, 78229
NeurogesX Investigational Site
St Louis, Missouri, 63108
NeurogesX Investigational Site
Wellesley Hills, Massachusetts, 02481-2106
NeurogesX Investigational Site
West Des Moines, Iowa, 50265
About this study
Official title: A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).
- Conditions
- Herpes Zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies
- Being tested
- Capsaicin Dermal Patch
- Keywords
- Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies, Complementary Therapies
- Medical subject headings
- Herpes Zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies
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 posted7 May 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082316
- Sponsor's protocol ID
- C111
- Status last verified
- Jan 2008
- First submitted
- 5 May 2004
- Last updated
- 11 Jan 2008
- Results posted
- No
Publications
Webster LR, Peppin JF, Murphy FT, Lu B, Tobias JK, Vanhove GF. Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain. Diabetes Res Clin Pract. 2011 Aug;93(2):187-197. doi: 10.1016/j.diabres.2011.04.010. Epub 2011 May 25.
PubMed 21612836
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00082316
- Acronym / sponsor ID
- C111
- Conditions
- Herpes Zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies
- Keywords
- Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- First posted
- 7 May 2004 (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.
This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
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 11 Jan 2008.
- Derived from this study: PubMed 21612836Webster LR, Peppin JF, Murphy FT, Lu B, Tobias JK, Vanhove GF. Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain. Diabetes Res Clin Pract. 2011 Aug;93(2):187-197. doi: 10.1016/j.diabres.2011.04.010. Epub 2011 May 25.
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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.
17 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 Capsaicin Dermal Patch in people with Herpes Zoster and Neuralgia, run by NeurogesX at 17 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 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082316, which also lists 1 linked publication.
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 Jan 2008.