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Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia Clinical research trials and Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia. Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia clinical trial. Participants oftentimes recieve the finest healthcare available for their Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia  Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
For Condition: Pain,Peripheral Nervous System Diseases,Neuralgia,Herpes Zoster
Status: No longer recruiting
Sponsor(s): NeurogesX ,
Synopsis: The purpose of the study is to assess the efficacy, safety and tolerability of NGX 4010 applied for 60 minutes for the treatment of PHN.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. At least 18 years of age. 2. Be in good health. 3. Diagnosis of postherpetic neuralgia (PHN) made by the primary treating physician or Investigator, and at least 3 months post-vesicle crusting. 4. Screening Pain Sum Score of 12 to 36. 5. Intact, unbroken skin over the painful area(s) to be treated. 6. If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study. 7. Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit. 8. All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following experimental drug exposure. 9. Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: completing a daily pain diary, attending all study visits, and refraining from elective surgery and extensive travel during study participation.) Exclusion Criteria: 1. Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose. 2. Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone®, as judged by the Investigator. 3. Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator. 4. Recent use (within 21 days preceding the Treatment Visit [Day 0]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas. 5. Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine). 6. Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis) or fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain. 7. Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. (Investigational treatment with NGX-4010 is not allowed in these areas.) 8. Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain. 9. Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), local anesthetics, Roxicodone® or adhesives. 10. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events.
Total Enrollment: 150
Location and Contact Information:
Georgia Medical Research Institute
Marietta, Georgia, 30060
United States
The Center for Clinical Research
Winston Salem, North Carolina, 27103
United States
Medex Healthcare Research
St. Louis, Missouri, 63108
United States
Progressive Clinical Research
San Antonio, Texas, 78229
United States
Tampa Medical Group
Tampa, Florida, 33614
United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, 30328
United States
Pivotal Research Center
Mesa, Arizona, 85210
United States
Advanced Pain Institute
Duarte, California, 91010
United States
Healthcare Research LLC
St. Louis, Missouri, 63141
United States
Anchor Research Center
Naples, Florida, 34102
United States
CNS Clinical Trials
Ft. Myers, Florida, 33907
United States
Lifetree Clinical Research
Salt Lake City, Utah, 84107
United States
Boston Clinical Trials
Brighton, Massachusetts, 02135
United States
Kaiser Permanente
Santa Rosa, California, 95403
United States
Hope Research Institute
Phoenix, Arizona, 85032
United States
Bradenton Neurology, Inc.
Bradenton, Florida, 34205
United States
Renaissance Clinical Research And Hypertension Clinic
Dallas, Texas, 75235
United States
Pivotal Research Center
Peoria, Arizona, 85381
United States
Comprehensive Neuroscience, Inc.
Boynton Beach, Florida, 33437
United States
Additional Information:
Study ID Numbers: C110;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068081
Other Neuralgia 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. Shingles Prevention Study
4. Dextromethorphan Versus Placebo for Neuropathic Pain
5. Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Related Studies:
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Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
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