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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)

This study has been completed.
Sponsor:
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00916942
First received: June 8, 2009
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Postherpetic Neuralgia
Drug: capsaicin 8%
Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by NeurogesX:

Primary Outcome Measures:
  • Duration of patch application [ Time Frame: Day of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment [ Time Frame: Day of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NGX-4010 patch Drug: capsaicin 8%
High concentration capsaicin 8% dermal patch applied for one hour
Experimental: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
Pre-treatment for NGX-4010
Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
Pre-treatment for NGX-4010

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00916942

Locations
United States, Florida
Anchor Research Center
Naples, Florida, United States, 34102
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33702
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Missouri
A & A Pain Institute
St. Louis, Missouri, United States, 63141
United States, North Carolina
Clinical Trials of America, Inc.
Hickory, North Carolina, United States, 28601
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
NeurogesX
  More Information

No publications provided

Responsible Party: Trudy Vanhove, MD, Medical Monitor, NeurogesX
ClinicalTrials.gov Identifier: NCT00916942     History of Changes
Other Study ID Numbers: C123
Study First Received: June 8, 2009
Last Updated: September 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by NeurogesX:
Tolerability study

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Capsaicin
Lidocaine
Prilocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Antipruritics
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014