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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00617461 |
Purpose
The purpose of this study is evaluate the difference between two doses of XP13512/GSK1838262 on pain associated with post-herpetic neuralgia
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Associated With Post-Herpetic Neuralgia |
Drug: XP13512/GSK1838262 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
| Official Title: | Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment. |
| Estimated Enrollment: | 98 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
XP13512: Experimental
1200mg and 3600mg
|
Drug: XP13512/GSK1838262
1200mg and 3600mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior to randomization, subjects eligible for enrollment in the study must meet all of the following criteria:
Subjects with the above definition of PHN must satisfy the following criteria to be eligible for the study:
Subjects may previously have been on >1800 mg/day of gabapentin since diagnosis of PHN.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Examples of such medical conditions include:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| GSK Investigational Site | |
| Roseville, California, United States, 95661 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94109 | |
| GSK Investigational Site | |
| Oxnard, California, United States, 93030 | |
| United States, Florida | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33612 | |
| GSK Investigational Site | |
| Marianna, Florida, United States, 32446 | |
| GSK Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| GSK Investigational Site | |
| Naranja, Florida, United States, 33032 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33603 | |
| GSK Investigational Site | |
| Daytona Beach, Florida, United States, 32117 | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| GSK Investigational Site | |
| Miami Springs, Florida, United States, 33166 | |
| GSK Investigational Site | |
| Chipley, Florida, United States, 32428 | |
| GSK Investigational Site | |
| Fort Myers, Florida, United States, 33916 | |
| GSK Investigational Site | |
| Bradenton, Florida, United States, 34209 | |
| GSK Investigational Site | |
| Gainesville, Florida, United States, 32608 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60617 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| GSK Investigational Site | |
| Florissant, Missouri, United States, 63031 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63117 | |
| United States, Montana | |
| GSK Investigational Site | |
| Missoula, Montana, United States, 59808 | |
| United States, New Hampshire | |
| GSK Investigational Site | |
| Lebanon, New Hampshire, United States, 03766 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10004 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Salisbury, North Carolina, United States, 28144 | |
| GSK Investigational Site | |
| Greensboro, North Carolina, United States, 27408 | |
| GSK Investigational Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Norman, Oklahoma, United States, 73071 | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Medford, Oregon, United States, 97501 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Greensburg, Pennsylvania, United States, 15601 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77028 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78238 | |
| GSK Investigational Site | |
| Longview, Texas, United States, 75605 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77089 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77044 | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78756 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Weber City, Virginia, United States, 24290 | |
| United States, Washington | |
| GSK Investigational Site | |
| Yakima, Washington, United States, 98902 | |
| GSK Investigational Site | |
| Wenatchee, Washington, United States, 98801 | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 10435 | |
| GSK Investigational Site | |
| Berlin, Germany, 10409 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Schoenau, Baden-Wuerttemberg, Germany, 69250 | |
| Germany, Hessen | |
| GSK Investigational Site | |
| Wiesbaden, Hessen, Germany, 65189 | |
| GSK Investigational Site | |
| Huettenberg, Hessen, Germany, 35625 | |
| Germany, Niedersachsen | |
| GSK Investigational Site | |
| Achim, Niedersachsen, Germany, 28832 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44892 | |
| GSK Investigational Site | |
| Hattingen, Nordrhein-Westfalen, Germany, 45525 | |
| Germany, Rheinland-Pfalz | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55116 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01307 | |
| GSK Investigational Site | |
| Leipzg, Sachsen, Germany, 04109 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 110527 |
| Study First Received: | February 6, 2008 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00617461 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
Neuropathic pain Post-herpetic neuralgia(PHN) |
|
Neuralgia, Postherpetic Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Pain Membrane Transport Modulators Signs and Symptoms Neuromuscular Diseases Sensory System Agents |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Neuralgia Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Peripheral Nervous System Diseases Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |