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Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Primary Purpose

Herpes Zoster, Neuralgia, Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Capsaicin Dermal Patch
Sponsored by
NeurogesX
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring Dermal assessment, Pain measurement, Diary, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes zoster/*complication/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral nervous system diseases/*complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years of age. Be in good health. Diagnosis of postherpetic neuralgia (PHN) made by the primary treating physician or Investigator, and at least 3 months post-vesicle crusting. Screening Pain Sum Score of 12 to 36. Intact, unbroken skin over the painful area(s) to be treated. If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study. Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit. 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 experimental drug exposure. Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: completing a daily pain diary, attending all study visits, and refraining from elective surgery and extensive travel during study participation.) Exclusion Criteria: 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. Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone®, as judged by the Investigator. Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator. Recent use (within 21 days preceding the Treatment 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. Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine). Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis) or fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain. Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. (Investigational treatment with NGX-4010 is not allowed in these areas.) Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain. Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), local anesthetics, Roxicodone® or adhesives. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events.

Sites / Locations

  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 5, 2003
Last Updated
March 4, 2008
Sponsor
NeurogesX
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1. Study Identification

Unique Protocol Identification Number
NCT00068081
Brief Title
Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Official Title
A Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NeurogesX

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to assess the efficacy, safety and tolerability of NGX 4010 applied for 60 minutes for the treatment of PHN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases
Keywords
Dermal assessment, Pain measurement, Diary, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes zoster/*complication/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral nervous system diseases/*complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capsaicin Dermal Patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age. Be in good health. Diagnosis of postherpetic neuralgia (PHN) made by the primary treating physician or Investigator, and at least 3 months post-vesicle crusting. Screening Pain Sum Score of 12 to 36. Intact, unbroken skin over the painful area(s) to be treated. If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study. Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit. 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 experimental drug exposure. Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: completing a daily pain diary, attending all study visits, and refraining from elective surgery and extensive travel during study participation.) Exclusion Criteria: 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. Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone®, as judged by the Investigator. Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator. Recent use (within 21 days preceding the Treatment 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. Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine). Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis) or fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain. Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. (Investigational treatment with NGX-4010 is not allowed in these areas.) Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain. Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), local anesthetics, Roxicodone® or adhesives. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events.
Facility Information:
Facility Name
NeurogesX Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
NeurogesX Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
NeurogesX Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
NeurogesX Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
NeurogesX Investigational Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
NeurogesX Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
NeurogesX Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
NeurogesX Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
NeurogesX Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
NeurogesX Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
NeurogesX Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
NeurogesX Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
NeurogesX Investigational Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
NeurogesX Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
NeurogesX Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
NeurogesX Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
NeurogesX Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
NeurogesX Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NeurogesX Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20937130
Citation
Webster LR, Tark M, Rauck R, Tobias JK, Vanhove GF. Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. BMC Neurol. 2010 Oct 11;10:92. doi: 10.1186/1471-2377-10-92.
Results Reference
derived

Learn more about this trial

Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

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