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CompletedNCT00916942Updated Sep 9, 2009

Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN)

A Phase 2 interventional study of capsaicin 8% and Lidocaine (2.5%)/Prilocaine (2.5%) Cream in Postherpetic Neuralgia, sponsored by NeurogesX. Completed at 6 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-09-09.

Sponsored by NeurogesX · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed.

Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.

02

Conditions studied

  • Postherpetic Neuralgia

Keywords

  • Tolerability study
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 20 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

NeurogesX is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between 18 and 90 years of age, inclusive.
  2. Be in good health.
  3. Prior diagnosis of PHN with pain persisting at least 3 months following shingles vesicle crusting.
  4. Pain due to PHN that, in the opinion of the investigator, is of appropriate severity for treatment with NGX-4010. The subject should have completed at least 3 NPRS scores.
  5. Intact, unbroken skin over the painful area(s) to be treated.
  6. Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit.
  7. All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following study termination.
  8. Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during study participation.)
  9. Subjects must sign an informed consent form for this study approved by the IRB. -

Exclusion criteria

Exclusion Criteria:

  1. Receipt of NGX-4010 open label or blinded study patches within 12 weeks of the Study Patch Application Visit (Day 0).
  2. Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
  3. Unavailability of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxycodone or other analgesic, as judged by the Investigator.
  4. Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism) judged likely to recur during the study period by the investigator.
  5. Recent use (within 7 days preceding the Study Patch Application Visit [Day 0]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
  6. Current or use within the past 30 days of any investigational agent
  7. Patients treated with class I (such as tocainide and mexiletine) or III anti-arrhythmic drugs.
  8. Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
  9. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
  10. Patients with congenital or idiopathic methemoglobinemia
  11. Patients with glucose-6-phosphate dehydrogenase deficiencies
  12. Uncontrolled (systolic blood pressure ≥ 175 mmHg or diastolic blood pressure ≥105 mmHg) or unstable hypertension
  13. Clinically significant cardiovascular disease defined as cerebrovascular accident, transient ischemic attack, myocardial infarction, unstable angina, stable angina, current arrhythmia, coronary artery disease, any heart surgery including coronary artery bypass graft surgery or percutaneous coronary angioplasty/stent placement, or valvular heart disease within the past 6 months
  14. Clinically significant abnormal ECG at screening.
  15. Clinically significant abnormal labs at screening.
  16. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function.
  17. Active malignancy or past history of malignancy during the past 5 years (history of squamous cell carcinoma or basal cell carcinoma of the skin are exempted from the exclusion criteria except if they occurred in the area of treatment).
  18. Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
  19. Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), or any components of the capsaicin patch, Cleansing Gel, oxycodone, hydrocodone, or adhesives.
  20. Patients with a known history of sensitivity to local anesthetics (including lidocaine and prilocaine) of the amide type or to any other component of the product
  21. Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    NGX-4010 patch

    Drug: capsaicin 8%

  • Experimental
    Lidocaine (2.5%)/Prilocaine (2.5%) Cream

    Pre-treatment for NGX-4010

    Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream

Interventions

  • Drugcapsaicin 8%

    High concentration capsaicin 8% dermal patch applied for one hour

  • DrugLidocaine (2.5%)/Prilocaine (2.5%) Cream

    Pre-treatment for NGX-4010

06

What researchers measure

Primary outcomes

  1. Duration of patch application

    Time frame: Day of treatment

Secondary outcomes

  1. Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment

    Time frame: Day of treatment

07

Study locations

6 sites
  • Anchor Research Center
    Naples, Florida 34102, United States
  • Comprehensive NeuroScience, Inc.
    St. Petersburg, Florida 33702, United States
  • Drug Studies America
    Marietta, Georgia 30060, United States
  • A & A Pain Institute
    St. Louis, Missouri 63141, United States
  • Clinical Trials of America, Inc.
    Hickory, North Carolina 28601, United States
  • Lifetree Clinical Research
    Salt Lake City, Utah 84106, United States
08

References and documents

Publications

  • Webster LR, Nunez M, Tark MD, Dunteman ED, Lu B, Tobias JK, Vanhove GF. Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia. BMC Anesthesiol. 2011 Dec 19;11:25. doi: 10.1186/1471-2253-11-25. PubMed 22182397 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00916942
Lead sponsor
NeurogesX
First posted
Jun 10, 2009
Start date
Jun 2009
Primary completion
Jun 2009
Completion
Jul 2009
Last update
Sep 9, 2009
View the source record on ClinicalTrials.gov ↗

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