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Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain

Primary Purpose

Neuralgia, Pain, Peripheral Nervous System Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capsaicin Patch
Sponsored by
NeurogesX
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Capsicum, Pepper, Dermal assessment, Pain measurement, Diary, PHN, Postherpetic Neuralgia, allodynia, hyperalgesia, shingles, varicella

Eligibility Criteria

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

Eligibility Criteria Inclusion Criteria: Patients may be eligible for this study if they: Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting. Are in good health. Have an adequate pain score during the screening period. Have painful areas (maximum of two sites) below the neck. If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile. If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure. Have unbroken skin with good perfusion over the painful area(s). Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream. Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study. Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches. Are 18 years of age or older. Are willing and able to comply with the protocol Exclusion Criteria: Patients will not be eligible for this study if they: Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated. Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain. Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas. Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin. Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator). Currently have an abuse problem with alcohol (from self-report or as judged by investigator). Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician. Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain. Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician. Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation. Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives. Have a high tolerance to opioids. Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).

Sites / Locations

  • Arizona Research Center
  • University of Arizona Health Sciences Center
  • Anchor Research Center
  • Palm Beach Neurological Center
  • Suncoast Neuroscience Associates, Inc.
  • Brigham and Women's Hospital, Pain Trials Center
  • University of Utah Pain Management Center
  • University of Wisconsin Hospital, Neurology Department

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 1, 2002
Last Updated
February 6, 2006
Sponsor
NeurogesX
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1. Study Identification

Unique Protocol Identification Number
NCT00034710
Brief Title
Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
Official Title
A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NeurogesX

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Pain, Peripheral Nervous System Diseases, Herpes Zoster
Keywords
Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Capsicum, Pepper, Dermal assessment, Pain measurement, Diary, PHN, Postherpetic Neuralgia, allodynia, hyperalgesia, shingles, varicella

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capsaicin Patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria Inclusion Criteria: Patients may be eligible for this study if they: Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting. Are in good health. Have an adequate pain score during the screening period. Have painful areas (maximum of two sites) below the neck. If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile. If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure. Have unbroken skin with good perfusion over the painful area(s). Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream. Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study. Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches. Are 18 years of age or older. Are willing and able to comply with the protocol Exclusion Criteria: Patients will not be eligible for this study if they: Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated. Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain. Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas. Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin. Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator). Currently have an abuse problem with alcohol (from self-report or as judged by investigator). Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician. Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain. Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician. Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation. Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives. Have a high tolerance to opioids. Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Jermano
Organizational Affiliation
NeurogesX
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Brigham and Women's Hospital, Pain Trials Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Utah Pain Management Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Wisconsin Hospital, Neurology Department
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain

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