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

This study has been completed.
Sponsor:
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00034710
First received: May 1, 2002
Last updated: February 6, 2006
Last verified: February 2006
  Purpose

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.


Condition Intervention Phase
Neuralgia
Pain
Peripheral Nervous System Diseases
Herpes Zoster
Drug: Capsaicin Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by NeurogesX:

Estimated Enrollment: 42
Study Start Date: March 2002
Estimated Study Completion Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  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: NCT00034710

Locations
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Florida
Anchor Research Center
Naples, Florida, United States, 34102
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33410
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
United States, Massachusetts
Brigham and Women's Hospital, Pain Trials Center
Boston, Massachusetts, United States, 02115
United States, Utah
University of Utah Pain Management Center
Salt Lake City, Utah, United States, 84108
United States, Wisconsin
University of Wisconsin Hospital, Neurology Department
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
NeurogesX
Investigators
Study Director: John A Jermano NeurogesX
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034710     History of Changes
Other Study ID Numbers: C102
Study First Received: May 1, 2002
Last Updated: February 6, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by NeurogesX:
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

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Herpes Zoster
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014