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

Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuralgia; Pain; Peripheral Nervous System Diseases; Herpes Zoster

Intervention: Capsaicin Patch (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: NeurogesX

Official(s) and/or principal investigator(s):
John A Jermano, Study Director, Affiliation: NeurogesX

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.

Clinical Details

Official title: A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Arizona Research Center, Phoenix, Arizona 85023, United States

University of Arizona Health Sciences Center, Tucson, Arizona 85724, United States

Anchor Research Center, Naples, Florida 34102, United States

Palm Beach Neurological Center, Palm Beach Gardens, Florida 33410, United States

Suncoast Neuroscience Associates, Inc., St. Petersburg, Florida 33701, United States

Brigham and Women's Hospital, Pain Trials Center, Boston, Massachusetts 02115, United States

University of Utah Pain Management Center, Salt Lake City, Utah 84108, United States

University of Wisconsin Hospital, Neurology Department, Madison, Wisconsin 53792, United States

Additional Information

Starting date: March 2002
Last updated: February 6, 2006

Page last updated: August 20, 2015

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