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

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeurogesX
• Treatments: Capsaicin

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).