Clinical trial NCT00034710: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2002-05-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital, Pain Trials Center
state: Massachusetts
city: Salt Lake City
country: United States
facility: University of Utah Pain Management Center
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Hospital, Neurology Department
state: Wisconsin
Study officials:
affiliation: NeurogesX
name: John A Jermano
role: STUDY_DIRECTOR
References: