Clinical trial NCT00034710 (phase 2, status: completed)
Conditions: neuralgia, pain, peripheral nervous system diseases, herpes zoster
ICD codes: G50.0, M54.81, B02.22, M79.2, N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, G64, M35.06, P14.9, P14.8, C47.9, D36.10, R94.138, B02.39
Drugs: capsaicin patch
SMILES: COC1=C(O)C=CC(CNC(=O)CCCC\C=C\C(C)C)=C1
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).