Herpes ZosterPhase 2NCT00089557
An Open-Label Extension Study of 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.
Trial summary
This study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114 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
- No sites listed yet
- 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 completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7 days) before entry into Study C114.
- Demonstrated adherence to protocol requirements during Study C111, and willing and able to comply with protocol requirements for the duration of the study participation.
- Must not have had any serious adverse experience since enrollment in Study C111, whether or not considered to be study drug-related.
- 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 (36 weeks).
- Must not use topical pain medications on painful areas.
- Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
- No history or current problem with substance abuse.
About this study
This study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114
- 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, Pain, 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 posted9 Aug 2004 (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
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089557
- Sponsor's protocol ID
- C114
- Status last verified
- Sep 2004
- First submitted
- 6 Aug 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00089557
- Acronym / sponsor ID
- C114
- Conditions
- Herpes Zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies
- Keywords
- Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- First posted
- 9 Aug 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 an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114
Study design
- Primary purpose
- Treatment
- 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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
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.
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: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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 24 Jun 2005.