Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
This study has been terminated.
(Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes)
Sponsor:
NeurogesX
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00085761
First received: June 14, 2004
Last updated: March 4, 2008
Last verified: March 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Peripheral Nervous System Diseases Pain |
Drug: Capsaicin Dermal Patch |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by NeurogesX:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085761
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085761
Locations
| United States, Florida | |
| NeurogesX Investigational Site | |
| Sarasota, Florida, United States, 34239 | |
| United States, Virginia | |
| NeurogesX Investigational Site | |
| Annandale, Virginia, United States, 22003 | |
Sponsors and Collaborators
NeurogesX
More Information
| ClinicalTrials.gov Identifier: | NCT00085761 History of Changes |
| Other Study ID Numbers: |
C112 |
| Study First Received: | June 14, 2004 |
| Last Updated: | March 4, 2008 |
Keywords provided by NeurogesX:
|
Dermal assessment Pain measurement Diary Neuropathy Analgesics/*therapeutic use |
Capsaicin/*administration & dosage/adverse effects HIV Infections/*complications/*drug therapy Pain Complementary Therapies |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2017