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| Sponsor: | NeurogesX |
|---|---|
| Information provided by: | NeurogesX |
| ClinicalTrials.gov Identifier: | NCT00321672 |
Purpose
The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain HIV Infections Peripheral Nervous System Diseases |
Drug: Capsaicin Dermal Patch |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy |
| Estimated Enrollment: | 480 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Study C119 is a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects will have painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive). Painful areas of up to 1000 square centimeters will be treated during a single treatment administration in this study. Subjects will be randomly assigned to receive active NGX-4010 patches or low-concentration control patches that are identical in appearance, at doses (patch application duration) of either 30 or 60 minutes, according to a 2:1:2:1 allocation scheme.
Subjects may be on stable chronic oral pain medication regimens, but currently will not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours will be recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14). Subjects will continue to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects will return for interim follow-up visits at Weeks 4 and 8 following study treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | C119 |
| Study First Received: | May 2, 2006 |
| Last Updated: | March 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00321672 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Analgesics Capsaicin Neuropathic pain Neuropathy Distal sensory polyneuropathy |
Peripheral neuropathy Dermal assessment Pain measurement Analgesics |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Nervous System Diseases Infection Capsaicin Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases |
Neuromuscular Diseases Sensory System Agents HIV Infections Therapeutic Uses Peripheral Nervous System Diseases Sexually Transmitted Diseases Lentivirus Infections Antipruritics Peripheral Nervous System Agents Dermatologic Agents Retroviridae Infections |