Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
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ClinicalTrials.gov Identifier: NCT00085761 |
Recruitment Status :
Terminated
(Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes)
First Posted : June 17, 2004
Last Update Posted : March 6, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Peripheral Nervous System Diseases Pain | Drug: Capsaicin Dermal Patch | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085761
United States, Florida | |
NeurogesX Investigational Site | |
Sarasota, Florida, United States, 34239 | |
United States, Virginia | |
NeurogesX Investigational Site | |
Annandale, Virginia, United States, 22003 |
ClinicalTrials.gov Identifier: | NCT00085761 |
Other Study ID Numbers: |
C112 |
First Posted: | June 17, 2004 Key Record Dates |
Last Update Posted: | March 6, 2008 |
Last Verified: | March 2008 |
Dermal assessment Pain measurement Diary Neuropathy Analgesics/*therapeutic use |
Capsaicin/*administration & dosage/adverse effects HIV Infections/*complications/*drug therapy Pain Complementary Therapies |
HIV Infections Nervous System Diseases Peripheral Nervous System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Neuromuscular Diseases Capsaicin Antipruritics Dermatologic Agents Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |