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

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ClinicalTrials.gov Identifier: NCT00916942
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : September 9, 2009
Sponsor:
Information provided by:
NeurogesX

Tracking Information
First Submitted Date  ICMJE June 8, 2009
First Posted Date  ICMJE June 10, 2009
Last Update Posted Date September 9, 2009
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2009)
Duration of patch application [ Time Frame: Day of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00916942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2009)
Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment [ Time Frame: Day of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN)
Official Title  ICMJE An Open-Label Study Of The Use Of Topical Lidocaine (2.5%)/Prilocaine (2.5%) Cream As Pre-Treatment For NGX-4010 In Subjects With Postherpetic Neuralgia (PHN)
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia
Intervention  ICMJE
  • Drug: capsaicin 8%
    High concentration capsaicin 8% dermal patch applied for one hour
  • Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
    Pre-treatment for NGX-4010
Study Arms  ICMJE
  • Experimental: NGX-4010 patch
    Intervention: Drug: capsaicin 8%
  • Experimental: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
    Pre-treatment for NGX-4010
    Intervention: Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 9, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00916942
Other Study ID Numbers  ICMJE C123
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trudy Vanhove, MD, Medical Monitor, NeurogesX
Study Sponsor  ICMJE NeurogesX
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NeurogesX
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP