HIV InfectionsPhase 3NCT00085761
Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
A Phase 3 study testing Capsaicin Dermal Patch in people with HIV Infections and Peripheral Nervous System Diseases, run by NeurogesX at 2 sites in United States.
Trial summary
The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Peripheral Nervous System Diseases, Pain
- What is being tested?
- Capsaicin Dermal Patch
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 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 have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
- Must not have significant pain in feet 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 for HIV-associated neuropathy.
- Must be able to comply with study requirements such as completing daily pain diary and attending study visits.
- Must be at least 18 years old, not pregnant, and be 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
2 sites in 1 country.
United States2 sites
NeurogesX Investigational Site
Annandale, Virginia, 22003
NeurogesX Investigational Site
Sarasota, Florida, 34239
About this study
Official title: An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.
- Conditions
- HIV Infections, Peripheral Nervous System Diseases, Pain
- Being tested
- Capsaicin Dermal Patch
- Keywords
- Dermal assessment, Pain measurement, Diary, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, HIV Infections/*complications/*drug therapy, Pain, Complementary Therapies
- Medical subject headings
- HIV Infections, Peripheral Nervous System Diseases, Pain
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 posted17 Jun 2004 (estimated)
Why it stopped: Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085761
- Sponsor's protocol ID
- C112
- Status last verified
- Mar 2008
- First submitted
- 14 Jun 2004
- 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
- An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
- ClinicalTrials.gov ID
- NCT00085761
- Acronym / sponsor ID
- C112
- Conditions
- HIV Infections, Peripheral Nervous System Diseases, Pain
- Keywords
- Dermal assessment, Pain measurement, Diary, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, HIV Infections/*complications/*drug therapy, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- First posted
- 17 Jun 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.
The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.
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 was stopped early (reason given: Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes). Results are not available in the source record.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsaicin Dermal Patch in people with HIV Infections and Peripheral Nervous System Diseases, run by NeurogesX at 2 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: stopped early, 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 2 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 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 was stopped early (reason given: Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes). 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 6 Mar 2008.