NGX-4010 for the Treatment of Postherpetic Neuralgia
This study has been completed.
Sponsor:
NeurogesX
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00061776
First received: June 3, 2003
Last updated: March 4, 2008
Last verified: March 2008
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Purpose
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles |
Drug: Capsaicin Dermal Patch |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia |
Resource links provided by NLM:
Further study details as provided by NeurogesX:
| Estimated Enrollment: | 300 |
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).
Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Eligibility Criteria:
- Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain.
- Must not have significant pain due to causes other than PHN (for example, arthritis).
- Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
- Must have intact and unbroken 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 (1-year).
- Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain.
- Must not use topical pain medications for PHN.
- Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation.
- No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
- No history or current problem with substance abuse.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061776
Show 28 Study Locations
Show 28 Study LocationsSponsors and Collaborators
NeurogesX
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00061776 History of Changes |
| Other Study ID Numbers: | C108 |
| Study First Received: | June 3, 2003 |
| Last Updated: | March 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NeurogesX:
|
Dermal assessment Pain measurement Diary Shingles Neuropathy Analgesics/*therapeutic use |
Capsaicin/*administration & dosage/adverse effects Herpes Zoster/*complications/drug therapy Neuralgia/*drug therapy/etiology Pain Peripheral Nervous System Diseases/*complications |
Additional relevant MeSH terms:
|
Herpes Zoster Nervous System Diseases Neuralgia Peripheral Nervous System Diseases Neuralgia, Postherpetic Herpesviridae Infections DNA Virus Infections Virus Diseases Pain Neurologic Manifestations |
Neuromuscular Diseases Signs and Symptoms Capsaicin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Antipruritics Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013