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

NCT00034710 | Completed Phase 2

• 1 other identifier: C102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Interventions

Capsaicin Patch DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• NeurogesX: lead

Study Sites (8)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Anchor Research Center

Naples, Florida, 34102, United States

Location

Palm Beach Neurological Center

Palm Beach Gardens, Florida, 33410, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33701, United States

Location

Brigham and Women's Hospital, Pain Trials Center

Boston, Massachusetts, 02115, United States

Location

University of Utah Pain Management Center

Salt Lake City, Utah, 84108, United States

Location

University of Wisconsin Hospital, Neurology Department

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Neuralgia; Pain; Peripheral Nervous System Diseases; Herpes Zoster; Neuralgia, Postherpetic; Hyperalgesia; Chickenpox

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Somatosensory Disorders; Sensation Disorders

Study Officials

• John A Jermano

  NeurogesX

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2002
• First Posted: May 2, 2002
• Study Start: March 1, 2002
• Study Completion: October 1, 2002
• Last Updated: February 7, 2006

Record last verified: 2006-02

Locations

US (8)