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Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain Clinical research trials and Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain. Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain clinical trial. Participants oftentimes recieve the most expert healthcare available for their Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain  Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
For Condition: Neuralgia,Pain,Herpes Zoster,Peripheral Nervous System Diseases
Status: No longer recruiting
Sponsor(s): NeurogesX ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment:
Location and Contact Information:
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
United States
University of Utah Pain Management Center
Salt Lake City, Utah, 84108
United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410
United States
Brigham and Women's Hospital, Pain Trials Center
Boston, Massachusetts, 02115
United States
Arizona Research Center
Phoenix, Arizona, 85023
United States
University of Wisconsin Hospital, Neurology Department
Madison, Wisconsin, 53792
United States
Anchor Research Center
Naples, Florida, 34102
United States
Additional Information:
Study ID Numbers: C102;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034710
Other Pain Studies:
1. NGX-4010 for the Treatment of Postherpetic Neuralgia
2. Tolerability of Three Local Anesthetic Formulations in Conjunction with NGX-4010 for the Treatment of Neuropathic Pain
3. Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
4. Shingles Prevention Study
5. Dextromethorphan Versus Placebo for Neuropathic Pain
Related Studies:
Other Pain Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
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